Evidence-Based Medicine




Anesthesia in Patients With Traumatic Facial Injury ( Chapter 1.1 )


Clinical Question:


What are the comparative benefits and harms of general and local anesthesia in patients with traumatic facial injury?


Author Recommendation:


In adults with acute facial trauma, in order to improve patient satisfaction and reduce pain and adverse effects, anesthesiologists, surgeons, and patients should participate in shared decision-making regarding selection of local or general anesthesia based on fracture localization, severity, comorbidities, and individual patient preferences.


What Does the Evidence Conclude?



















Quality of Evidence a Strength of Recommendations b Evidence
Low Weak Nasal bone fractures
Evidence suggests that general anesthesia is associated with greater patient satisfaction with anesthesia and patient satisfaction with appearance of the nose when compared with local anesthesia in adults with acute nasal bone fractures.
The evidence regarding outcomes in patients with different demographics, fracture severity, and comorbidities as well as provider characteristics is insufficient.
Very low Weak Mandibular fractures
Evidence suggests that there are no differences in patient or surgeon satisfaction between general and regional anesthesia in adults with acute mandibular fractures. However, regional anesthesia reduces the duration of pain and need for rescue analgesics and decreases the risk of postoperative nausea, vomiting, and sore throat when compared with general anesthesia.
The evidence regarding outcomes in patients with different demographics, fracture severity, and comorbidities as well as provider characteristics is insufficient.

a Quality of Evidence scale (GRADE): high, moderate, low, and very low. For more information on the GRADE rating system, see gdt.guidelinedevelopment.org/app/handbook/handbook.html


b The Guideline Elements Model: gem.med.yale.edu.easyaccess1.lib.cuhk.edu.hk/default.htm .



What Are the Parameters of Our Evidence Search?





















PICO
Population


  • Children or adults with facial fractures due to facial trauma



  • Patient demographics



  • Location of fracture:




    • Upper: cranium, cranial base, orbital roof, frontal sinus



    • Middle: nasal, naso-orbito-ethmoid (NOE) fractures, zygoma, zygomaticomaxillary complex (ZMC) fractures, Le Fort fractures, orbital floor, medial wall



    • Lower: mandible




  • Surgical intervention (open, closed, septoplasty, septorhinoplasty, rhinoplasty)

Intervention


  • General anesthesia

Comparator


  • Local anesthesia

Primary outcome(s)


  • Patient and surgeon satisfaction with anesthesia and surgical results



  • Pain, need for rescue analgesics



  • Quality of life



  • Treatment utilization, need for subsequent corrective surgeries



  • All harms, including postoperative nausea and vomiting, postoperative sore throat



Basis for and Determinants of the Strength of Recommendations:


Population:


Adults with acute nasal bone fractures


Setting:


Inpatient


Intervention:


General anesthesia


Comparator:


Local anesthesia



GRADE SUMMARY OF FINDINGS TABLE 1

Comparative Benefits and Harms of General and Local Anesthesia in Adults With Acute Nasal Bone Fractures




































































































Outcomes Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
Patient satisfaction with anesthesia 838 917 RR 0.9 (0.8;1.0) 140 (1 RCT) Very low No difference
Patient satisfaction with anesthesia 386 379 RR 1.2 (1.0;1.3) 427 (5 observational studies) Low Favors general anesthesia
Patient satisfaction with function of the nose 38 25 RR 1.5 (0.4;6.2) 248 (2 observational studies) Low No difference
Patient satisfaction with appearance of the nose 141 44
Attributable events per 1000 treated 98 (2;194)
RR 3.3 (1.4;7.9)
NNT 10 (5;500)
277 (3 observational studies) Low Favors general anesthesia
Patient preference for treatment if the nose were to refracture 789 879 RR 0.8 (0.6;1.2) 189 (2 RCTs) Very low No difference
Patient preference for treatment if the nose were to refracture 331 305 RR 1.0 (0.4;2.5) 248 (2 observational studies) Very low No difference
Subsequent corrective surgeries
Subgroup: septoplasty
45 85 RR 0.5 (0.2;1.1) 437 (4 observational studies) Low No difference
Subsequent corrective surgeries
Subgroup: septorhinoplasty
323 257 RR 1.3 (0.7;2.1) 139 (1 RCT) Very low No difference
Subsequent corrective surgeries
Subgroup: septorhinoplasty
33 67 RR 0.6 (0.1;3.3) 466 (5 observational studies) Low No difference
Subsequent corrective surgeries
Subgroup: refracted
77 119 RR 0.6 (0.2;1.9) 124 (1 RCT) Very low No difference
Subsequent corrective surgeries
Subgroup: rhinoplasty
15 25 RR 0.6 (0.1;3.7) 248 (2 observational studies) Low No difference

Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; NNT, number needed to treat to achieve an outcome in 1 patient; RCT, randomized controlled trial; RR, relative risk.


Population:


Adults with mandibular fracture


Setting:


Inpatient


Intervention:


General anesthesia


Comparator:


Sedation with a regional block, with the use of a peripheral nerve stimulator



GRADE SUMMARY OF FINDINGS TABLE 2

Comparative Benefits and Harms of General and Local Anesthesia in Adults With Acute Mandibular Fractures




































































Outcomes Fracture Location Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
Patient satisfaction: Good or Excellent 880 960 RR 0.9 (0.8;1.1) 50 (1 RCT) Very low No difference
Surgeon satisfaction: Good or Excellent 960 960 RR 1.0 (0.9;1.1) 50 (1 RCT) Very low No difference
Pain-free interval, min NR NR MD −98.8 ( 117.7; 79.9)
SMD 2.9 ( 3.7; 2.1)
50 (1 RCT) Very low Favors local anesthesia
Rescue analgesics NR NR MD 2.6 (2.2;3.0)
SMD 3.3 (2.4;4.1)
50 (1 RCT) Very low Favors local anesthesia
Amount of blood loss, mL NR NR MD 8.0 (−61.7;77.7)
SMD 0.1 (−0.5;0.6)
50 (1 RCT) Very low
Postoperative nausea and vomiting 320 40
Attributable events per 1000 treated 280 (82;478)
RR 8.0 (1.1;59.3)
NNT 4 (2;12)
50 (1 RCT) Very low Favors local anesthesia
Postoperative sore throat 280 0
Attributable events per 1000 treated 280 (98;462)
RR 15.0 (0.9;249.3)
NNT 4 (2;10)
50 (1 RCT) Very low Favors local anesthesia

Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; NNT, number needed to treat to achieve an outcome in 1 patient; NR, not reported; RCT, randomized controlled trial; RR, relative risk.

Between studies, differences in continuous outcomes: MD, mean difference in absolute values of continuous outcomes between intervention and comparator; SMD, standardized mean difference between intervention and comparator where the magnitude of the effect is defined as small (SMD, 0–0.5 standard deviations), moderate (SMD, 0.5–0.8 standard deviations), and large (SMD >0.8 standard deviations).


Guideline Recommendations:


American Association of Oral and Maxillofacial Surgeons. Clinical Practice Guidelines for Oral and Maxillofacial Surgery, 2012. (AGREE II Score: Unavailable)





  • This guideline recommends assessment of favorable therapeutic outcomes from anesthesia:




    • Recovery of the patient from the anesthetic effects, returning to his or her preanesthetic physiological and psychological state within an appropriate time after the cessation of the administration of the anesthetic drugs



    • Agreement that the anesthetic experience was satisfactory by both the surgeon and the patient



    • Recovery from the administration of sedatives, anesthetic agents, and other adjunctive medications



    • Patient (family) acceptance of procedure and understanding of outcomes




  • This guideline recommends general or local anesthesia, depending on patient preferences and at the discretion of the treating surgeon and anesthesiologist.



Author Commentary:


Background


Facial trauma presents difficulties in managing the patient’s airway and sharing it between the anesthesiologists and surgeons. We systematically reviewed the comparative benefits and harms of general and local anesthesia in patients with facial trauma.


Methods


Our team conducted a comprehensive search in PubMed, EMBASE, the Cochrane Library, the Elsevier text mining tool database including the National Institutes of Health RePORTER Grant database, and the clinicaltrials.gov trial registry up to June 2016 and did a hand-search of the reference lists. We searched for studies of children or adults with facial fractures due to facial trauma. We included all studies that examined the benefits and harms of general and local anesthesia.


Results


We identified a meta-analysis of 3 randomized and 5 nonrandomized studies and the additional publication of a single RCT. All studies reported outcomes in adult patients. We found no pediatric studies.


Nasal bone fractures


Low-quality evidence from observational studies suggests that general anesthesia is associated with greater patient satisfaction with anesthesia and patient satisfaction with appearance of the nose (RR 3.3; 95% CI 1.4;7.9) when compared with local anesthesia in adults with acute nasal bone fractures ( Table 1 ). In contrast with the observational studies, the single RCT demonstrates no differences in patient satisfaction between general and local anesthesia. There are no differences in need for additional surgery between general and local anesthesia ( Table 1 ). Studies did not report the comparative safety of anesthesia regimens.


Mandibular fractures


Very low-quality evidence from a single RCT suggests that there are no differences in patient or surgeon satisfaction between general and regional anesthesia in adults with acute mandibular fractures ( Table 2 ). However, regional anesthesia reduces the duration of pain and need for rescue analgesics and decreases the risk of postoperative nausea, vomiting (0.4% vs. 38%, respectively), and sore throat (0% vs. 28%, respectively) when compared with general anesthesia ( Table 2 ).


Limitations


We downgraded the quality of evidence due to risk of bias in the body of evidence and imprecision in treatment effects from small studies. The evidence regarding comparative effectiveness and harms of specific pharmacological agents used in anesthesiology regimens was insufficient.


We found one guideline that describes general goals of various types of anesthesia but does not recommend specific indications to select general over local anesthesia. Future research is needed to examine the comparative effectiveness and safety of anesthesia regimens and agents in subpopulations by demographics, comorbidities, and provider experience and the quality of provided care.


Conclusions


In adults with acute facial trauma in order to improve patient satisfaction and reduce pain and adverse effects, anesthesiologists, surgeons, and patients should participate in shared decision-making regarding selection of local or general anesthesia based on fracture localization, severity, comorbidities, and individual patient preferences.


Glossary:


AGREE II, Appraisal of Guidelines for Research and Evaluation; CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development and Evaluation; MD, mean difference; NNT, number needed to treat to achieve an outcome in 1 patient; NR, not reported; RCT, randomized controlled trial; RePORTER, National Institutes of Health Research Portfolio Online Reporting Tools federalreporter-nih-gov.easyaccess1.lib.cuhk.edu.hk/ ; RR, relative risk; SMD, standardized mean difference.


Recommended Citation:


Dorafshar AH, Shamliyan TA; Elsevier Evidence-based Medicine Center: Evidence Report: Anesthesia in patients with traumatic facial injury. Elsevier Evidence-Based Medicine Center. May 11, 2017.




Antibiotic Use in Patients With Traumatic Facial Injury ( Chapter 1.1 )


Clinical Question:


What are the benefits and harms of preventive antibiotic treatment in patients with traumatic facial injury?


Author Recommendation:


In adults with facial trauma, in order to reduce mortality and infection rates, clinicians should not recommend postoperative antibiotics in addition to pre- and perioperative antibiotics.


What Does the Evidence Conclude?























Quality of Evidence a Strength of Recommendations b Evidence
Low Weak Upper facial trauma
Evidence suggests no reduction in the risk of local wound infections after additional postoperative preventive antibiotics in adults with orbital blow-out fractures who received pre- and perioperative preventive antibiotics.
Evidence suggests that preventive antibiotics administered at the time of primary treatment of the basilar skull fractures did not reduce all-cause or meningitis-related mortality, incidence of meningitis, or any other infections, regardless of the presence of cerebrospinal fluid leakage.
Very low Weak Middle facial fractures
Evidence suggests no reduction in the risk of infections after additional postoperative preventive antibiotics in adults with zygomatic fractures or fractures of maxillary sinus who received pre- and perioperative preventive antibiotics.
Low Weak Lower facial fractures
Evidence suggests no reduction in the risk of infections after additional postoperative preventive antibiotics in adults with mandibular fractures or in adults undergoing orthognathic surgery who received pre- and perioperative preventive antibiotics.

a Quality of Evidence scale (GRADE): high, moderate, low, and very low. For more information on the GRADE rating system, see gdt.guidelinedevelopment.org/app/handbook/handbook.html


b The Guideline Elements Model: gem.med.yale.edu.easyaccess1.lib.cuhk.edu.hk/default.htm .



What Are the Parameters of Our Evidence Search?





















PICO
Population


  • Children or adults with facial fractures due to facial trauma



  • Patient demographics



  • Location of fracture:




    • Upper: cranium, cranial base, orbital roof, frontal sinus



    • Middle: nasal, naso-orbito-ethmoid (NOE) fractures, zygoma, zygomaticomaxillary complex (ZMC) fractures, Le Fort fractures, orbital floor, medial wall



    • Lower: mandible


Intervention


  • Preventive antibiotics: type, dose, route, duration



  • Preoperative: ≥2 hours before surgery



  • Perioperative: <2 hours before surgery and during surgery



  • Postoperative: after surgery

Comparator


  • No antibiotics or placebo

Primary outcome(s)


  • All-cause mortality; infection-related mortality



  • Infection, defined as purulent drainage from the surgical or fracture site, increased facial swelling beyond postoperative day 7, fistula formation at the surgical or fracture site with evidence of drainage, fever associated with local evidence of infection (swelling, erythema, or tenderness)



  • Severity of infection, defined as:




    • Grade I: Erythema around suture line limited to 1 cm



    • Grade II: 1–5 cm of erythema



    • Grade III: Greater than 5 cm of erythema and induration



    • Grade IV: Purulent drainage, either spontaneously or by incision and drainage



    • Grade V: Fistulae




  • Quality of life



  • Treatment utilization



  • All harms, including antibiotic adverse effects and resistance



Basis for and Determinants of the Strength of Recommendations:


Population:


Adults with upper facial fractures: basilar skull fractures


Setting:


Inpatient


Intervention:


Preventive antibiotics administered at the time of primary treatment of the basilar skull fracture


Comparator:


No preventive antibiotics



GRADE SUMMARY OF FINDINGS TABLE 1

Preventive Antibiotic Treatments in Adults With Basilar Skull Fractures












































































Outcomes Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
All-cause mortality 46 30 RR 1.5 (0.4;5.5) 208 (4 RCTs) Low No difference
Meningitis-related mortality 9 10 RR 1.0 (0.1;9.6) 208 (4 RCTs) Low No difference
Frequency of meningitis 92 141 RR 0.8 (0.4;1.6) 208 (4 RCTs) Low No difference
Meningitis
Subgroup: cerebrospinal fluid leakage (rhinorrhea or otorrhea)
78 146 RR 0.8 (0.4;1.8) 92 (3 RCTs) Low No difference
Meningitis
Subgroup: no cerebrospinal fluid leakage
113 151 RR 0.8 (0.3;2.1) 106 (2 RCTs) Low No difference
Meningitis
Subgroup: presence of cerebrospinal fluid leakage not specified
0 0 RR undetermined 10 (1 RCT) Very low No difference
Non-central nervous system infection
Subgroup: cerebrospinal fluid leakage (rhinorrhea or otorrhea)
154 231 RR 0.7 (0.2;2.1) 52 (1 RCT) Low No difference
Need for surgical correction in patients with cerebrospinal fluid leakage 0 0 RR undetermined 109 (1 RCT) Very low No difference

Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; RCT, randomized controlled trial; RR, relative risk.


Population:


Adults: orbital blow-out fractures


Setting:


Inpatient


Intervention:


Amoxicillin/clavulanic acid 1.2 g intravenously every 8 hours from admission until 24 hours postoperatively, followed by amoxicillin/clavulanic acid 625 mg orally every 8 hours for another 4 days


Comparator:


Amoxicillin/clavulanic acid 1.2 g intravenously every 8 hours from admission until 24 hours postoperatively



GRADE SUMMARY OF FINDINGS TABLE 2

Preventive Antibiotic Treatments in Adults With Orbital Blow-Out Fractures




















Outcomes Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
Local wound infections 69 30 RR 2.3 (0.2;23.8) 62 (1 RCTs) Very low No difference

Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; RCT, randomized controlled trial; RR, relative risk.


Population:


Adults with middle facial fractures


Setting:


Inpatients


Intervention:


Preventive postoperative antibiotics administered after pre- and perioperative antibiotics


Comparator:


Preventive pre- and perioperative antibiotics without postoperative antibiotics



GRADE SUMMARY OF FINDINGS TABLE 3

Preventive Postoperative Antibiotic Treatment in Adults With Middle Facial Fractures








































































Outcomes Fracture Location Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
Facial Fracture
Cefazolin, 2 g, 20 Minutes Before Surgery and Cefazolin, 1 g Every 6 Hours for 24 Hours After Surgery Versus Cefazolin, 2 g, 20 Minutes Before Surgery
Postoperative infection 31 140 RR 0.2 (0.0;1.8) 75 (1 RCT) Very low No difference
Le Fort and Zygomatic Fractures
Amoxicillin/Clavulanic Acid 1.2 g Intravenously Every 8 Hours From Admission Until 24 Hours Postoperatively, Followed by Amoxicillin/Clavulanic Acid 625 mg Orally Every 8 Hours for Another 4 Days Versus Amoxicillin/Clavulanic Acid 1.2 g Intravenously Every 8 Hours From Admission Until 24 Hours Postoperatively
Local wound infections 44 41 RR 1.1 (0.2;7.4) 94 (1 RCT) Very low No difference
Purulent infection 22 20 RR 1.1 (0.1;16.9) 94 (1 RCT) Very low No difference
Infection NR NR RR (crude) 1.6 (0.1;32.5) 124 (1 observational study) Very low No difference
Fractures of the Maxillary Sinus
Amoxicillin/Clavulanate or Levofloxacin for 3 Days After Surgery Versus No Postoperative Antibiotics
Acute sinusitis 960 880 RR 1.1 (0.9;1.3) 50 (1 RCT) Very low No difference
Serious infection NR NR Reported as nonsignificant 242 (1 observational study) Very low No difference

Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; NR, not reported; RCT, randomized controlled trial; RR, relative risk.


Population:


Adults with lower facial fractures


Setting:


Inpatient


Intervention:


Preventive postoperative antibiotics administered after pre- and perioperative antibiotics


Comparator:


Preventive pre- and perioperative antibiotics without postoperative antibiotics



GRADE SUMMARY OF FINDINGS TABLE 4

Preventive Antibiotic Treatments in Adults With Lower Facial Fractures
















































Outcomes Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
Mandibular Fractures
Postoperative infection 127 150 RR 0.8 (0.5;1.5) 273 (3 RCTs) Low No difference
Surgical site infection NR NR RR (crude) 0.52 (0.22;1.23) 510 (1 observational study) No difference
Orthognathic Surgery
Additional antibiotics 118 235 RR 0.5 (0.1;2.4) 34 (1 RCT) Very low No difference
Morbidity scores NR NR 264 vs. 406 ( P = .04) 34 (1 RCT) Very low No difference

Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; NR, not reported; RCT, randomized controlled trial; RR, relative risk.


Guideline Recommendations:


American Association of Oral and Maxillofacial Surgeons. Clinical Practice Guidelines for Oral and Maxillofacial Surgery, 2012. (AGREE II Score: Unavailable)





  • This guideline recommends the use of antimicrobial rinses and systemic antibiotics to prevent infections related to surgery in certain circumstances.



  • The decision to employ prophylactic perioperative antibiotics is at the discretion of the treating surgeon and should be based on the patient’s clinical condition as well as other comorbidities that may be present, including diabetes mellitus, malnutrition, and autoimmune or immune-deficit disorders.



Author Commentary:


Background


Prevention of infectious complications is among the most important goals in the management of facial injuries. We systematically reviewed benefits and harms from preventive antibiotic treatments in patients with upper, middle, and lower facial trauma.


Methods


Our team conducted a comprehensive search in PubMed, EMBASE, the Cochrane Library, the Elsevier text mining tool database including the National Institutes of Health RePORTER Grant database, and the clinicaltrials.gov trial registry up to June 2016 and did a hand-search of the reference lists. We searched for studies of children or adults with facial fractures due to facial trauma and analyzed the data separately for upper (cranial base, orbital roof, or frontal sinus), middle (nasal, naso-orbito-ethmoid, zygoma, zygomaticomaxillary complex, Le Fort, orbital floor, or medial wall), and lower (mandibular) fracture. We included all studies that examined the benefits and harms of preventive antibiotics administered before, during, and after surgery.


We abstracted the number of patients with and without outcomes among treatment groups and means and standard deviations of continuous measures of pain and quality of life. We used random effects models with inverse variance weighting at 95% confidence limits and examined heterogeneity based on I-squared variation in relative risk or absolute risk difference attributable to heterogeneity in treatment effects. We used Stata software for all calculations. Correction coefficients for zero events were used as a default option in Stata software, and intention to treat analyses were used for evidence synthesis. For statistically significant differences in absolute risk difference, we calculated number needed to treat and attributable events per 1000 treated.


For randomized studies, we used the Cochrane Risk of Bias tool at outcome level. A low risk of bias was assumed when RCTs met all the risk-of-bias criteria, and a high risk of bias was assumed if 1 or more risk-of-bias criteria were not met. An unknown risk of bias was assigned for the studies with poorly reported risk-of-bias criteria. We assigned the quality of evidence ratings as high, moderate, low, or very low, according to risk of bias in the body of evidence, directness of comparisons, precision and consistency in treatment effects, and the evidence of reporting bias, using GRADE methodology. Treatment effect estimates were defined as precise when the total number of events was greater than 250. Justification of the sample size was not included in grading of the evidence. We did not conduct post hoc statistical power analyses. A high quality of evidence was assigned to well-designed RCTs with consistent findings. The quality of evidence was downgraded to moderate if at least 1 of 4 quality-of-evidence criteria was not met; for example, moderate quality of evidence was assigned if there was a high risk of bias in the body of evidence or if the results were inconsistent or imprecise. The quality of evidence was downgraded to low if 2 criteria were not met, and to very low when >2 criteria are not met.


A low quality of evidence was assigned to nonrandomized studies and upgraded if there was a strong (relative risk > 2) or dose–response association. Evidence was defined as insufficient when no studies provided valid information about treatment effects. This approach was applied regardless of whether the results were statistically significant.


Results


We identified 1 high-quality meta-analysis, 5 systematic reviews, 8 RCTs, and 12 nonrandomized studies. All studies reported outcomes in adult patients. We found no pediatric studies.


Upper facial trauma


Low-quality evidence suggests that preventive antibiotics administered at the time of primary treatment of the basilar skull fractures did not reduce all-cause (RR 1.5; 95% CI 0.4; 5.5) or meningitis-related mortality (RR 1.0; 95% CI 0.1; 9.6), incidence of meningitis (RR 0.8; 95% CI 0.4; 1.6), or any other infections, regardless of the presence of cerebrospinal fluid leakage (208 patients in 4 RCTs; Table 1 ).


Orbital blow-out fractures


Very low-quality evidence from a single RCT suggests no reduction in the risk of local wound infections after a postoperative 4-day course of antibiotics in adults with orbital blow-out fractures (RR 2.3; 95% CI 0.2;23.8). In this RCT, all patients received amoxicillin/clavulanic acid from admission until 24 hours postoperatively and then were randomly assigned to an additional 4 days of postoperative amoxicillin/clavulanic acid or placebo ( Table 2 ).


Middle facial fractures


Very low-quality evidence from single RCTs and observational studies suggests that preventive postoperative antibiotics administered after pre- and perioperative antibiotics did not prevent infections in adults with zygomatic fractures or fractures of maxillary sinus when compared with pre- and perioperative antibiotics alone (585 adults, 3 RCTs and 2 observational studies; Table 3 ).


Lower facial fractures


Low-quality evidence suggests that preventive postoperative antibiotics administered after pre- and perioperative antibiotics did not prevent infections when compared with preventive pre- and perioperative antibiotics alone in adults with mandibular fractures (783 adults, 3 RCTs and 1 observational study; Table 4 ).


Very low-quality evidence from single small RCTs suggests that preventive postoperative antibiotics administered after pre- and perioperative antibiotics did not prevent infections when compared with preventive pre- and perioperative antibiotics alone in adults undergoing orthognathic surgery (34 adults, 1 RCT; Table 4 ).


Preoperative antibiotics


Published systematic reviews of a few old RCTs, case series from single institutions, and expert surveys suggest that preoperative antibiotics are effective in reducing the risk of infections in patients with facial trauma. A performance improvement program implemented early antibiotic administration in patients with open fractures, but the evidence regarding reduction of infection rates in patients with facial trauma is sparse.


Limitations


We downgraded the quality of evidence due to risk of bias in the body of evidence and heterogeneity and imprecision in treatment effects from small studies. We did not meta-analyze and did not grade the quality of evidence from case series that described institutional experiences and failed to provide adjusted relative measures of associations. The evidence regarding comparative effectiveness and harms of specific antibiotics was insufficient. Primary studies did not report pain, depression, or quality of life. Studies did not report outcomes in patients with different demographics, although the evidence suggests racial disparities in the treatment outcomes of head fractures. No studies examined antibiotic resistance in patients with facial trauma.


We found one guideline that recommends preoperative antibiotics in patients undergoing oral and maxillofacial surgery at the discretion of treating surgeons. Future research is needed to examine the comparative effectiveness and safety of preventive antibiotics in patients with facial trauma and various demographic groups and comorbidities. Conducting randomized trials in adults with acute trauma is difficult. Sharing individual patient data in a facial trauma registry may shed light on the benefits and harms of antibiotics in real-life clinical settings.


Conclusions


In adults with facial trauma, in order to reduce mortality and infection rates, clinicians should not recommend postoperative antibiotics in addition to pre- and perioperative antibiotics.


Glossary:


AGREE II, Appraisal of Guidelines for Research and Evaluation; CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development and Evaluation; NNT, number needed to treat to achieve an outcome in 1 patient; NR, not reported; RCT, randomized controlled trial; RePORTER, National Institutes of Health Research Portfolio Online Reporting Tools federalreporter-nih-gov.easyaccess1.lib.cuhk.edu.hk/ ; RR, relative risk.


Recommended Citation:


Dorafshar AH, Shamliyan TA; Elsevier Evidence-based Medicine Center: Evidence Report: Antibiotic use in patients with traumatic facial injury. Elsevier Evidence-Based Medicine Center. February 14, 2017.




Postoperative Imaging Following Facial Fracture Repair ( Chapter 1.3 )


Clinical Question:


What are the benefits and harms of postoperative imaging following facial fracture repair?


Author Recommendation:


In adults with acute facial trauma in order to ensure correct alignment, facial surgeons should practice postoperative imaging. Provider experience, baseline complication rates and the quality of provided care should guide a decision to use post-surgical imaging in individual patients instead of routine post-surgical imaging.


What Does the Evidence Conclude?















Quality of Evidence a Strength of Recommendations b Evidence
Very low Weak Evidence suggests that unfavorable postprocedure imaging is not associated with lower rates of reoperation and has very low predictive value for early detection of postsurgical complications. Routine postoperative imaging is cost-effective only in settings with complication rates above 17.7%.
The evidence regarding the effects of postsurgical imaging on quality of life, patient satisfaction, and medicolegal actions is insufficient.

a Quality of Evidence scale (GRADE): high, moderate, low, and very low. For more information on the GRADE rating system, see gdt.guidelinedevelopment.org/app/handbook/handbook.html


b The Guideline Elements Model: gem.med.yale.edu.easyaccess1.lib.cuhk.edu.hk/default.htm .



What Are the Parameters of Our Evidence Search?





















PICO
Population


  • Children or adults with facial fractures due to facial trauma repaired by open reduction and internal fixation



  • Patient demographics



  • Location of fracture:




    • Upper: cranium, cranial base, orbital roof, frontal sinus



    • Middle: nasal, naso-orbito-ethmoid (NOE) fractures, zygoma, zygomaticomaxillary complex (ZMC) fractures, Le Fort fractures, orbital floor, medial wall



    • Lower: mandible


Intervention


  • Any postsurgical imaging

Comparator


  • No imaging

Primary outcome(s)


  • Hospital length of stay, reoperation rate, readmission rate, differences in management, optic nerve damage, cost-effectiveness, medicolegal actions



  • Noncomparative outcomes in imaged patients: bone alignment, plate position in those receiving plates



Basis for and Determinants of the Strength of Recommendations:


Population:


Adults with facial fractures


Settings:


Any


Intervention:


Unfavorable postprocedural imaging


Comparator:


Unremarkable (favorable) postprocedural imaging



GRADE SUMMARY OF FINDINGS TABLE 1

Comparative Benefits and Harms of Postprocedural Imaging in Adults With Facial Fractures














































































Patient Population Outcomes Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
Unfavorable Postoperative Radiographs in Adults With Facial Fractures
Repeat surgery NR NR OR 4.71 (0.22;99.64) 257 (1 observational study) Very low No difference
Reduction Less Than 100% Versus 100% in Postoperative CT in Adults With Zygomaticomaxillary Fracture Managed by Closed Reduction
Having symptoms NR NR OR 4.26 (1.09;18.44) 51 (1 observational study) Very low Positive association
Remaining Dislocation 6–10 mm Versus No Dislocation in Postoperative CT in Adults With Zygomaticomaxillary Fracture Managed by Closed Reduction
Having symptoms NR NR OR 9.91 (0.89; 500) 51 (1 observational study) Very low No difference
Unfavorable Postoperative Radiographs in Adults With Isolated Mandibular Fractures
Short-term complications NR NR Sensitivity 20%
Specificity 5%
The positive predictive
value 20%
100 (1 observational study) Very low Low predictive value
Long-term complications 0 129 OR 0.43 (0.02;8.08) 92 (1 observational study) Very low No difference
Repeat surgery 0 71 OR 0.82 (0.04;15.93) 92 (1 observational study) Very low No difference
Postsurgical Decision to Revise According to Postoperative Mirrored CT in Adults With Unilateral Orbital Floor Fracture
Repeat surgery 1000 0 Sensitivity 0.31 (0.09;0.67)
Specificity 0.99 (0.85;1.00)
51 (1 observational study) Very low Low predictive value

Abbreviations: CT, computed tomography; GRADE, Grading of Recommendations Assessment, Development and Evaluation; NR, not reported; OR, odds ratio.


Guideline Recommendations:


American Association of Oral and Maxillofacial Surgeons. Clinical Practice Guidelines for Oral and Maxillofacial Surgery, 2012. (AGREE II Score: Unavailable)





  • This guideline does not address postprocedural imaging in patients with facial trauma but acknowledges that outcomes assessment may include an imaging evaluation.



Author Commentary:


Background


Therapeutic goals in treating patients with facial trauma include patient satisfaction with facial appearance and function without complications or repeated surgical procedures. Postsurgical panoramic radiography is common as a part of routine clinical practice in many hospitals. However, the benefits of postsurgical imaging for clinical decisions and patient outcomes are unclear. We systematically reviewed the association between postsurgical imaging and complications requiring repeated surgery in patients with facial trauma.


Methods


We conducted a comprehensive search in PubMed, EMBASE, the Cochrane Library, the Elsevier text mining tool database including the National Institutes of Health RePORTER Grant database, and the clinicaltrials.gov trial registry up to June 2016 and did a hand-search of the reference lists. We searched for studies of children or adults with facial fractures due to facial trauma. We included all studies that examined the benefits and harms of postsurgical imaging.


Results


We identified one qualitative narrative review, one cost-effectiveness analysis, and several poor-quality observational studies for this review. None of the studies compared patient outcomes in patients who had versus did not have postoperative imaging. Observational studies included adults with various facial fractures undergoing various imaging methods and did not use adjustment in reporting the rates of reoperation.


Very low-quality evidence suggests that unfavorable postprocedure imaging is not associated with lower rates of reoperation and has very low predictive value for early detection of postsurgical complications ( Table 1 ). The systematic review and an economic analysis concluded that routine postoperative imaging is cost-effective only in settings with a complication rate above 17.7%.


Limitations


We downgraded the quality of evidence due to risk of bias in the body of evidence and imprecision in treatment effects in small nonrandomized studies. The evidence regarding the effects of postsurgical imaging on quality of life, patient satisfaction, and medicolegal actions was insufficient.


Future research is needed to examine the comparative effectiveness and safety of various imaging techniques in association with provider experience and the quality of provided care.


Conclusions


In adults with acute facial trauma in order to ensure correct alignment, facial surgeons should practice postoperative imaging. Provider experience, baseline complication rates and the quality of provided care should guide a decision to use post-surgical imaging in individual patients instead of routine post-surgical imaging.


Glossary:


AGREE II, Appraisal of Guidelines for Research and Evaluation; CT, computed tomography; GRADE, Grading of Recommendations Assessment, Development and Evaluation; NR, not reported; OR, odds ratio; RePORTER, National Institutes of Health Research Portfolio Online Reporting Tools federalreporter-nih-gov.easyaccess1.lib.cuhk.edu.hk/ .


Recommended Citation:


Dorafshar AH, Shamliyan TA; Elsevier Evidence-based Medicine Center: Evidence Report: Postoperative imaging following facial fracture repair. Elsevier Evidence-Based Medicine Center. February 23, 2017.




Optimal Time to Surgery in Patients With Traumatic Orbital Fracture ( Chapter 1.9 )


Clinical Question:


What is the optimal time to surgery in patients with traumatic orbital fracture?


Author Recommendation:


In children and adults with orbital fractures in order to achieve a complete recovery and prevent postsurgical enophthalmos and residual diplopia, clinicians should not delay indicated surgical repair.


What Does the Evidence Conclude?















Quality of Evidence a Strength of Recommendations b Evidence
Very low Strong Evidence suggests that a delay in surgical repair is associated with poor clinical outcomes in most cases. The data is insufficient to determine the optimal surgical timing.
Expert opinion is that immediate, within 24 hours, surgical repair should be recommended for younger patients and patients with nonresolving oculocardiac reflex, blow-out orbital fractures, and early enophthalmos.
A poor prognosis of pediatric orbital fractures with entrapment resulting in a rapid development of muscle fibrosis and persistent diplopia may justify early surgical interventions in children with orbital fractures.

a Quality of Evidence scale (GRADE): high, moderate, low, and very low. For more information on the GRADE rating system, see gdt.guidelinedevelopment.org/app/handbook/handbook.html


b The Guideline Elements Model: gem.med.yale.edu.easyaccess1.lib.cuhk.edu.hk/default.htm .



What Are the Parameters of Our Evidence Search?





















PICO
Population Children or adults with orbital fractures due to facial trauma
Patient demographics
Presence or absence of entrapment
Intervention Shorter timing between the trauma and surgical intervention
Comparator Longer timing between the trauma and surgical intervention
Primary outcome(s) All-cause mortality, quality of life, function
Treatment utilization
All harms, including surgical complications


Basis for and Determinants of the Strength of Recommendations:


Population:


Adults with orbital fractures


Setting:


Inpatient


Intervention:


Shorter timing between the trauma and surgical intervention


Comparator:


Delay in timing between the trauma and surgical intervention



GRADE SUMMARY OF FINDINGS TABLE 1

Optimal Time to Surgery in Patients With Traumatic Orbital Fracture


































































































Outcomes Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
Surgery After <7 Days Versus >7 Days After Trauma
Complete resolution of diplopia 0 200 OR 0.3 (0.01;8.46) 10 (1 observational study) Very low No difference
Surgery After <2 Weeks Versus 2 Weeks to 6 Months After Trauma
Complete recovery 730 250 OR 6.9 (1.35;35.06) 29 (1 observational study) Very low Favors shorter timing
Surgery After <2 Weeks Versus >2 Weeks After Trauma in Patients With Blow-Out Fracture
Diplopia 63 149 Peto OR 0.3 (0.1;0.9) 442 cases Very low Favors shorter timing
Enophthalmos 33 81 Peto OR 0.2 (0.1;0.9) 442 cases Very low Favors shorter timing
Surgery After <30 Days Versus >30 Days After Trauma
Complete resolution of preoperative motility restriction 600 0 OR 24.6 (1.30;462.34) 40 (1 observational study of children) Very low Favors shorter timing
Complete resolution of diplopia 516 0 OR 19.2 (1.02;360.51) 40 (1 observational study of children) Very low Favors shorter timing
Surgery After <24 Hours Versus >24 Hours After Trauma
Residual diplopia 83 375 OR 0.2 (0.01;1.84) 20 (1 observational study of children) Very low No difference
Surgery After <4 Weeks Versus >4 Weeks After Trauma
Enophthalmos postoperative NR NR P < .05 22 (1 RCT) Very low Favors shorter timing
Surgery After <8 Weeks Versus >8 Weeks After Trauma
Enophthalmos postoperative 70 500 OR 0.1 (0.01;0.46) 51 (1 observational study) Very low Favors shorter timing

Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; NR, not reported; OR, odds ratio; RCT, randomized controlled trial.


Guideline Recommendations:


American Association of Oral and Maxillofacial Surgeons. Clinical Practice Guidelines for Oral and Maxillofacial Surgery, 2012. (AGREE II Score: Unavailable)





  • This guideline considers time elapsed since injury as a risk factor for poor outcome but does not specify the optimal time for the surgery of orbital fractures.



Author Commentary:


Background


Orbital fractures are common and result in patients suffering with enophthalmos (displacement of the eyeball within the orbit), diplopia, orbital soft tissue entrapment, and nerve injury. There is no consensus around optimal timing for surgical repair of the fractured orbital floor. We systematically reviewed benefits and harms from early versus delayed surgery for orbital fractures.


Methods


We conducted a comprehensive search in PubMed, EMBASE, the Cochrane Library, Elsevier text mining tool database including National Institutes of Health RePORTER grant database, and clinicaltrials.gov trial registry up to June 2016 and did a hand-search of the reference lists. We included all studies that examined timing of surgical treatments for orbital fractures.


Results


We identified one clinical and two systematic reviews, 1 RCT, and 16 nonrandomized studies. The RCT was designed to examine treatment options and provide post hoc analysis of the association between timing and patient outcomes. A very small observational case series compared different timing and failed to provide reproducible data and to adjust for patient characteristics, surgical techniques, or the quality of the provided care. Adult case series analyzed various orbital fractures. Pediatric case series analyzed mostly blow-out orbital fractures.


Very low-quality evidence suggests that a delay in surgical repair is associated with poor clinical outcomes in most case series ( Table 1 ). The data is insufficient to determine the optimal surgical timing. A clinical review speculated that immediate, within 24 hours, surgical repair should be recommended for younger patients and patients with nonresolving oculocardiac reflex, blow-out orbital fractures, and early enophthalmos ( Appendix ). Studies did not stratify outcome rates by baseline entrapment. However, pediatric case series acknowledge a poor sensitivity in diagnosis of entrapment by radiologists and poor prognosis of pediatric orbital fracture with entrapment, resulting in a rapid development of muscle fibrosis and persistent diplopia.


Limitations


We downgraded the quality of evidence due to risk of bias in the body of evidence and heterogeneity and imprecision in treatment effects from small observational studies. We could not meta-analyze the data from case series due to differences in timing of surgery and definition of patient outcomes. The exact reason for surgical delay was not reported in the studies.


A single guideline defines a delay in surgical treatment after injury as a risk factor for poor outcome after any facial trauma but does not specify the optimal time for the surgery of orbital fractures. Future research is needed to determine the optimal timing for surgical repair of orbital fractures in patient subpopulations.


Conclusions


In children and adults with orbital fractures, in order to achieve a complete recovery and prevent postsurgical enophthalmos and residual diplopia, clinicians should not delay indicated surgical repair.



APPENDIX

Clinical Recommendations for Repair of Isolated Orbital Floor Fractures (Modified From Burnstine Ma )
















Optimal Timing Computed Tomography Findings
Immediate
Within 24 hours
Diplopia present with computed tomography (CT) evidence of an entrapped muscle or periorbital tissue associated with a nonresolving oculocardiac reflex: bradycardia, heart block, nausea, vomiting, or syncope
“White-eyed blow-out fracture.” Young patients (<18 years), history of periocular trauma, little ecchymosis or edema (white eye), marked extraocular motility vertical restriction, and CT examination revealing an orbital floor fracture with entrapped muscle or perimuscular soft tissue
Early enophthalmos/hypoglobus causing facial asymmetry
Significant globe displacement vision-threatening emergency
Within 2 weeks Symptomatic diplopia with positive forced ductions, evidence of an entrapped muscle or perimuscular soft tissue on CT examination, and minimal clinical improvement over time
Large floor fracture causing latent enophthalmos
Significant hypo-ophthalmos
Progressive infraorbital hypesthesia
Observation Minimal diplopia (not in primary or downgaze), good ocular motility, and no significant enophthalmos or hypo-ophthalmos


Glossary:


AGREE II, Appraisal of Guidelines for Research and Evaluation; CI, confidence interval; CT, computed tomography; GRADE, Grading of Recommendations Assessment, Development and Evaluation; NR, not reported; OR, odds ratio; RCT, randomized controlled trial; RePORTER, National Institutes of Health Research Portfolio Online Reporting Tools federalreporter-nih-gov.easyaccess1.lib.cuhk.edu.hk/ .


Recommended Citation:


Dorafshar A, Shamliyan TA; Elsevier Evidence-based Medicine Center: Evidence Report: Optimal time to surgery in patients with traumatic orbital fracture. Elsevier Evidence-Based Medicine Center. March 1, 2017.




Role of Surgery Versus Medical Treatment for Traumatic Optic Nerve Compression ( Chapter 1.9 )


Clinical Question:


What is the comparative effectiveness of surgery versus medical treatment for traumatic optic nerve compression?


Author Recommendation:


In children and adults with traumatic optic nerve compression, in order to achieve some improvement in visual acuity, clinicians should recommend systemic corticosteroids and consider rescue surgery in individual patients who do not improve after systemic corticosteroids.


What Does the Evidence Conclude?



















Quality of Evidence a Strength of Recommendations a Evidence
Low Weak Evidence suggests that systemic corticosteroids increase the rates of improved visual acuity when compared with observation in adolescents and adults with traumatic nonpenetrating optic nerve compression.
Evidence suggests that there are no differences in the rates of improved visual acuity between methylprednisolone versus placebo, between dexamethasone versus methylprednisolone, or between megadoses versus high doses of methylprednisolone.
Very low Weak Evidence suggests that surgical optic nerve canal decompression alone or in combination with systemic corticosteroids increases the rates of improved visual acuity when compared with observation in adolescents and adults with traumatic nonpenetrating optic nerve compression.
However, surgical optic nerve canal decompression is not better than systemic corticosteroids in improving visual acuity.
Surgical optic nerve canal decompression combined with systemic corticosteroids is not better in improving visual acuity than systemic corticosteroids alone or surgery alone.

a Quality of Evidence scale (GRADE): high, moderate, low, and very low. For more information on the GRADE rating system, see gdt.guidelinedevelopment.org/app/handbook/handbook.html .


b The Guideline Elements Model: gem.med.yale.edu.easyaccess1.lib.cuhk.edu.hk/default.htm .



What Are the Parameters of Our Evidence Search?






















PICO
Population Children or adults with traumatic optic nerve compression
Patient demographics, time interval since trauma, unilateral or bilateral traumatic optic neuropathy, baseline visual acuity, comorbidities
Visual acuity






























Level Corresponding Abbreviation Corresponding Abilities of the Affected Eye
1 CF Count fingers Patient can see all the fingers of the hand from a distance of 30–50 cm
2 HM Hand motion Patient can see the movement of the hand
3 LP Light perception Patient can detect the light
4 NLP No light perception Patient cannot detect the light corresponding to the Italian system of 0/10
Intervention Corticosteroids (drug name, dose, frequency, duration, timing in relation to injury and surgery)
Megadose (30 mg/kg intravenous methylprednisone, followed by 5.4 mg/kg/hour for 24 hours)
High dose (1 g intravenous methylprednisolone/day)
Surgical optic nerve canal decompression (technique, combination with pre- and postsurgical steroids)
Comparator No active treatment (observation)
Primary outcome(s) Improvement in visual acuity as reported in the studies:
Increased in ≥1–3 lines of Snellen visual acuity or percent improvement in log of the minimum angle of resolution (log MAR); −0.1 change in the log MAR visual acuity score represents a one-line change in visual acuity
Count fingers (CF), hand motion (HM), light perception (LP), and no light perception (NLP)
Quality of life
Treatment utilization
All harms


Basis for and Determinants of the Strength of Recommendations:


Population:


Adolescents or adults with traumatic nonpenetrating optic nerve compression


Setting:


Inpatient


Intervention:


Systemic steroids within 7–14 days after injury


Comparator:


Placebo, no active treatment, or active comparators



GRADE SUMMARY OF FINDINGS TABLE 1

Systemic Steroids in Adolescents or Adults With Traumatic Nonpenetrating Optic Nerve Compression






















































































Outcomes Comparisons Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
Systemic Methylprednisolone Versus Placebo
Recovery of visual acuity defined as a decrease of at least 0.4 log MAR in visual acuity, 3 months 688 533 RR 1.3 (0.7;2.3) 31 (1 RCT) Very low No difference
Systemic Steroids Versus Observation
Improvement in visual acuity 449 346
Attributable events per 1000 treated 282 (112;453)
Peto OR 2.7 (1.5;4.9)
NNT 4 (2;9)
302 cases Low Favors systemic steroids
Visual acuity improved (log MAR) NR NR MD 37.3 (20.7;53.9)
SMD 0.8 (0.5;1.2)
113 cases Very low Favors systemic steroids
High-Dose Dexamethasone Versus Megadose of Methylprednisolone
Visual improvement >2 lines, 2–17 months 441 387 RR 1.4 (0.3;5.8) 65 (2 RCTs) Very low No difference
>3 lines improvement in best corrected visual acuities, 2 months
Subgroup: No light perception at baseline
400 400 RR 1.0 (0.2;4.6) 10 (1 RCT) Very low No difference
>3 lines improvement in best corrected visual acuities, 2 months
Subgroup: preserved finger counts at baseline
1000 1000 RR undetermined 9 (1 RCT) Very low No difference
Megadose Versus High Dose of Methylprednisolone
>1 lines improvement in visual acuity 923 875 OR 1.7 (0.1;31.9) 21 cases Very low No difference
Early (Within 24 Hours From Trauma) Versus Delayed (Within 7 Days From Trauma) Treatment With Prednisolone 20 mg/kg Body Weight/Day for 3 Days in Children
>1 line improvement in visual acuity 800 591 Peto OR 2.8 (0.3;29.0) 27 cases Very low No difference

Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; log MAR, log of the minimum angle of resolution; NNT, number needed to treat to achieve an outcome in 1 patient; NR, not reported; OR, odds ratio; RCT, randomized controlled trial; RR, relative risk.

Between studies, differences in continuous outcomes: MD, mean difference in absolute values of continuous outcomes between intervention and comparator; SMD, standardized mean difference between intervention and comparator where the magnitude of the effect is defined as small (SMD, 0–0.5 standard deviations), moderate (SMD, 0.5–0.8 standard deviations), and large (SMD >0.8 standard deviations).


Population:


Adolescents or adults with traumatic nonpenetrating optic neuropathy


Setting:


Inpatient


Intervention:


Surgical optic nerve canal decompression


Comparator:


Systemic Corticosteroids or Observation



GRADE SUMMARY OF FINDINGS TABLE 2

Surgical Optic Nerve Canal Decompression Versus Medical Treatments for Adolescents or Adults With Traumatic Nonpenetrating Optic Nerve Compression


































































































Outcomes Comparison Risk With Intervention Per 1000 Risk With Comparator Per 1000 Relative Measure of Association (95% Confidence Interval) Number of Participants (Studies) Quality (GRADE) Comments
Surgical Optic Nerve Canal Decompression Versus Observation
Improvement in visual acuity 397 105 Peto OR 4.1 (1.4;12.6) 77 cases Very low Favors surgery
Visual acuity improved (log MAR) NR NR MD 26.0 (9.5;42.5)
SMD 0.6 (0.2;1.0)
117 cases Very low Favors surgery
Surgical Optic Nerve Canal Decompression Versus Systemic Corticosteroids
Improvement in visual acuity 558 404 Peto OR 1.4 (0.9;2.1) 468 cases Very low No difference
Visual acuity improved (log MAR) NR NR MD −11.3 (−25.9;3.3)
SMD −0.3 (−0.6;0.1)
132 cases Very low No difference
Surgical Optic Nerve Canal Decompression Plus Systemic Corticosteroids Versus Observation
Visual acuity improved (log MAR) NR NR MD 20.9 (4.2;37.6)
SMD 0.5 (0.1;0.8)
112 cases Very low Favors surgery plus systemic corticosteroids
Surgical Optic Nerve Canal Decompression Plus Systemic Corticosteroids Versus Surgery Alone
Improvement in visual acuity, any 286 533 OR 0.4 (0.1;1.4) 36 cases Very low No difference
Surgical Optic Nerve Canal Decompression Plus Systemic Corticosteroids Versus Systemic Corticosteroids Alone
Improvement in visual acuity 313 471 Peto OR 0.5 (0.2;1.2) 100 cases Very low No difference
Surgical Optic Nerve Canal Decompression Plus Systemic Corticosteroids Within 7 Versus >7 Days After Injury
>3 lines improvement in visual acuity 696 238
Attributable events per 1000 treated 458 (196;719)
Peto OR 6.0 (1.9;19.4)
NNT 2 (1;5)
44 cases Very low Favors early treatment
Early (Within 7 Days) Versus Late (>7 Days After Injury) Endoscopic Optic Nerve Decompression and Postoperative Corticosteroid in Children
>3 lines improvement in visual acuity 964 462
Attributable events per 1000 treated 503 (223;782)
OR 31.5 (3.2;306.2)
NNT 2 (1;4)
41 cases Very low Favors early treatment

Abbreviations: GRADE, Grading of Recommendations Assessment, Development and Evaluation; log MAR, log of the minimum angle of resolution; NNT, number needed to treat to achieve an outcome in 1 patient; NR, not reported; OR, odds ratio.

Between studies, differences in continuous outcomes: MD, mean difference in absolute values of continuous outcomes between intervention and comparator; SMD, standardized mean difference between intervention and comparator where the magnitude of the effect is defined as small (SMD, 0–0.5 standard deviations), moderate (SMD, 0.5–0.8 standard deviations), and large (SMD >0.8 standard deviations).


Guideline Recommendations:


American Association of Oral and Maxillofacial Surgeons. Clinical Practice Guidelines for Oral and Maxillofacial Surgery, 2012. (AGREE II Score: Unavailable)


This guideline lists the following procedures for the management of orbital injuries but does not address preferred treatments for optic nerve compression:



  • A.

    Observation based on limited severity of fracture, displacement, and mobility


  • B.

    Open treatment (including endoscopically assisted and computed tomography-guided navigation)


  • C.

    Orbital reconstruction


  • D.

    Medial and/or lateral canthopexy


  • E.

    Nasolacrimal reconstruction


  • F.

    Antimicrobials as indicated


  • G.

    Control of pain


  • H.

    Drains for management of dead spaces or contaminated wounds when judgment dictates


  • I.

    Instructions for posttreatment care and follow-up



Author Commentary:


Background


Treatment options for traumatic optic nerve compression include observation, large dose of systemic corticosteroids, or surgical treatments, with no consensus on which option is superior to the others in preventing devastating blindness. The lack of direct randomized trials results in variable usual practices among hospitals and clinicians. We systematically reviewed the comparative effectiveness of surgical and medical treatment options for children and adults with traumatic optic nerve compression.


Methods


We conducted a comprehensive search in PubMed, EMBASE, the Cochrane Library, Elsevier text mining tool database including National Institutes of Health RePORTER Grant database, and clinicaltrials.gov trial registry up to August 2016 and did a hand-search of the reference lists. We used random effects models to pool relative risk from RCTs, Peto odds ratios from sparse controlled nonrandomized studies, and arcsine transformed crude rates of the outcomes from uncontrolled case series and case reports.


Results


We identified 4 meta-analyses, 1 systematic review, 3 RCTs, 1 controlled International Optic Nerve Trauma Study, and 42 publications of case series. Three Cochrane reviews did not provide quantitative data. Primary studies included children and adults and rarely reported results by age groups. The exact treatment regimens and outcomes measurements varied across individual reports. Primary studies of surgical treatments inconsistently reported concomitant use of pre- and postoperative systemic steroids. Many retrospective case series reported outcomes in patients who received surgery after systemic corticosteroids failed to improve visual acuity. Surgical techniques included extra- or intracranial, orbital, transethmoidal, or endoscopically assisted transconjunctival approaches. Studies did not compare different surgical techniques and did not explain the selection of the techniques used depending on patient characteristics.


Low-quality evidence suggests that systemic corticosteroids increase the rates of improved visual acuity when compared with observation in adolescents and adults with traumatic nonpenetrating optic nerve compression ( Table 1 ). Very low-quality evidence suggests that there are no differences in the rates of improved visual acuity between methylprednisolone versus placebo, between dexamethasone versus methylprednisolone, or between megadoses versus high doses of methylprednisolone ( Table 1 ).


Early (within 24 hours from trauma) versus delayed (within 7 days from trauma) prednisolone administration does not result in greater rates of improved visual acuity in children with traumatic nonpenetrating optic nerve compression ( Table 1 ).


Very low-quality evidence suggests that surgical optic nerve canal decompression alone or in combination with systemic corticosteroids increases the rates of improved visual acuity when compared with observation in adolescents and adults with traumatic nonpenetrating optic nerve compression ( Table 2 ). However, surgical optic nerve canal decompression is not better than systemic corticosteroids in improving visual acuity ( Table 2 ). Surgical optic nerve canal decompression combined with systemic corticosteroids is not better in improving visual acuity than systemic corticosteroids alone or surgery alone ( Table 2 ). Early surgery results in greater rates of improvement in visual acuity than later surgery in adults and children ( Table 2 ).


Indirect comparison of uncontrolled case series suggests that the rates of the improved visual acuity are slightly lower after observation and are very similar after systemic corticosteroids alone or after surgery in patients who did not experience improved vision after systemic corticosteroids ( Appendix Table 1 ). Uncontrolled case series suggest that patients with optic canal fracture and patients without baseline light perception have poor prognosis. The rates varied substantially among single institutions, probably because of differences in hospital protocols regarding indication for steroids or surgery, and probably due to differences in the quality of provided care.


Limitations


We downgraded the quality of evidence due to high risk of bias in the body of evidence and heterogeneity and imprecision in treatment effects from small studies. The evidence regarding comparative effects from various steroids and surgical techniques on complete vision restoration, mortality, quality of life, and treatment utilization was insufficient. Small studies attempted to examine correlation between baseline vision loss and treatment outcomes but failed to identify valid evidence for individualized treatment decisions. Authors came to the somewhat obvious conclusion that patients with minimal baseline vision loss have better vision after the treatments. Studies did not report outcomes in patients with different demographics or comorbidities.


We found one guideline that describes treatment options for orbital injuries but does not address preferred treatments for indirect optic nerve compression. Future research is needed to examine the comparative effectiveness and safety of surgical versus medical treatments in patients with traumatic optic nerve compression and various demographic groups and comorbidities.


Conclusions


In children and adults with traumatic optic nerve compression, in order to achieve some improvement in visual acuity, clinicians should recommend systemic corticosteroids and consider rescue surgery in individual patients who do not improve after systemic corticosteroids.



APPENDIX TABLE 1

Rates of Improvement in Visual Acuity After Different Treatments in Patients With Traumatic Nonpenetrating Optic Neuropathy




























Treatments % With Improvement (95% CI) * Cases
Conservative treatment 32.8 (23.6;45.5) 168 cases
Corticosteroids 54.9 (44.8;67.2) 250 cases
Surgery 54.9 (45.9;65.6) 304 cases
Surgery + steroid 35.0 (21.1;58.2) 61 cases
Surgery in patients who did not improve after systemic corticosteroids 57.8 (48.9;68.2) 1445 cases

Abbreviation: CI, confidence interval.

* Arcsine transformed and pooled with random effects model.



Glossary:


AGREE II, Appraisal of Guidelines for Research and Evaluation; CI, confidence interval; GRADE, Grading of Recommendations Assessment, Development and Evaluation; log MAR, log of the minimum angle of resolution; MD, mean difference; NNT, number needed to treat to achieve an outcome in 1 patient; NR, not reported; OR, odds ratio; RCT, randomized controlled trial; RePORTER, National Institutes of Health Research Portfolio Online Reporting Tools federalreporter-nih-gov.easyaccess1.lib.cuhk.edu.hk/ ; RR, relative risk.


Recommended Citation:


Dorafshar AH, Davidson E, Reddy S, et al. Role of surgery versus medical treatment for traumatic optic nerve compression. Elsevier Evidence-Based Medicine Center. March 1, 2017.




Fixation Points for Traumatic Zygomaticomaxillary Complex Fractures ( Chapter 1.12 )


Clinical Question:


What are the benefits and harms of various point fixation techniques in patients with traumatic zygomaticomaxillary complex fractures?


Author Recommendation:


In adults with isolated, laterally displaced zygomatic bone fractures, in order to achieve stable fixation and reduce vertical dystopia, clinicians should use 3-point over 2-point fixation with miniplates.


What Does the Evidence Conclude?























Quality of Evidence a Strength of Recommendations b Evidence
Very low Weak Evidence suggests that 3-point fixation results in higher rates of stable fracture fixation and smaller vertical dystopia when compared with 2-point fixation in adults with isolated, laterally displaced zygomatic bone fractures.
Very low Weak There are no differences in patient outcomes between single-point fixation with titanium miniplate versus single-point fixation with bioresorbable plates or between 1-point fixation with titanium miniplate versus fixation with Kirschner wire in adults with zygomatic complex fracture.
Insufficient Weak Uncontrolled case series suggest that the rates of beneficial treatment outcomes including patient satisfaction with postoperative appearance, facial symmetry, or stable fracture are more than 90% across various fixation points, while the rates of postsurgical complications and infections vary across institutions regardless of the number of fixation points.
4-point fixation results in bony union and facial symmetry in patients with isolated zygomatic arch fracture and insufficient intraoperative reduction after closed reduction and a single-fixation point.

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