Sydney C Butts1, Elizabeth Floyd2, Erica Lai3, Richard M Rosenfeld2, Timothy Doerr4. 1. Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology, State University of New York Downstate Medical Center, College of Medicine, Brooklyn. 2. Department of Otolaryngology, State University of New York Downstate Medical Center, Brooklyn. 3. School of Public Health, State University of New York Downstate Medical Center, Brooklyn. 4. Department of Otolaryngology, University of Rochester Medical Center, Rochester, New York.
Abstract
IMPORTANCE: The control of pain associated with mandibular fractures is an important treatment outcome that affects function, adherence to treatment regimens, and patient comfort and satisfaction. OBJECTIVE: To explore the pain management protocols reported in studies of mandibular fractures, including the reporting of quality-of-life measures. EVIDENCE REVIEW: PubMed/MEDLINE, EMBASE, Cochrane CENTRAL, and clinicaltrials.gov were searched for randomized clinical trials published from 1970 to July 2014. We followed PRISMA reporting standards to assess study eligibility and extract data. Studies of patients older than 16 years who underwent operative mandibular fracture management were included. The primary data collected included the type of analgesic prescribed, associated adverse effects of the analgesic, method of pain assessment, and use of quality-of-life measures. A pain attentiveness score was assigned to studies based on the comprehensiveness of the information reported. Several variables were reviewed to determine the factors that predict reporting of pain-related data. Assessments of risk for bias were performed using the Cochrane Collaboration's domain-based evaluation method. FINDINGS: The initial search identified 111 articles, of which 38 met inclusion criteria. Among the 38 reviewed articles, there were 38 trials and 1808 unique patients represented. Among the 38 articles, the procedures reported included maxillomandibular fixation only in 6 (16%), open reduction with internal fixation only in 20 (53%), and both in 12 (32%). Specific analgesics prescribed were reported in only 5 of the 38 studies (13%), and 3 of these used a combination of nonsteroidal anti-inflammatory drugs and acetaminophen (paracetamol). Thirteen studies (34%) reported pain assessments and 5 (13%) included quality-of-life measures. Geographic region was the only variable that predicted pain attentiveness, with studies from Europe (3 of 11 studies [27%]) and Asia (6 of 16 studies [38%]) most likely to have a high pain attentiveness score. A low rating was least common in the United States (2 of 5 studies [40%]) (P = .047, Fisher exact test). Most of the studies had unclear (n = 27) or high (n = 6) risks for bias in the key domains assessed. CONCLUSIONS AND RELEVANCE: Pain management is a neglected outcome in randomized clinical trials of mandibular trauma; most studies did not describe the specific analgesics used. Many randomized clinical trials (13 [34%]) assessed pain levels among patients without providing information about the agents prescribed. The incorporation of validated pain measures and quality-of-life scores in future studies of mandibular trauma would focus attention on this key outcome measure.
IMPORTANCE: The control of pain associated with mandibular fractures is an important treatment outcome that affects function, adherence to treatment regimens, and patient comfort and satisfaction. OBJECTIVE: To explore the pain management protocols reported in studies of mandibular fractures, including the reporting of quality-of-life measures. EVIDENCE REVIEW: PubMed/MEDLINE, EMBASE, Cochrane CENTRAL, and clinicaltrials.gov were searched for randomized clinical trials published from 1970 to July 2014. We followed PRISMA reporting standards to assess study eligibility and extract data. Studies of patients older than 16 years who underwent operative mandibular fracture management were included. The primary data collected included the type of analgesic prescribed, associated adverse effects of the analgesic, method of pain assessment, and use of quality-of-life measures. A pain attentiveness score was assigned to studies based on the comprehensiveness of the information reported. Several variables were reviewed to determine the factors that predict reporting of pain-related data. Assessments of risk for bias were performed using the Cochrane Collaboration's domain-based evaluation method. FINDINGS: The initial search identified 111 articles, of which 38 met inclusion criteria. Among the 38 reviewed articles, there were 38 trials and 1808 unique patients represented. Among the 38 articles, the procedures reported included maxillomandibular fixation only in 6 (16%), open reduction with internal fixation only in 20 (53%), and both in 12 (32%). Specific analgesics prescribed were reported in only 5 of the 38 studies (13%), and 3 of these used a combination of nonsteroidal anti-inflammatory drugs and acetaminophen (paracetamol). Thirteen studies (34%) reported pain assessments and 5 (13%) included quality-of-life measures. Geographic region was the only variable that predicted pain attentiveness, with studies from Europe (3 of 11 studies [27%]) and Asia (6 of 16 studies [38%]) most likely to have a high pain attentiveness score. A low rating was least common in the United States (2 of 5 studies [40%]) (P = .047, Fisher exact test). Most of the studies had unclear (n = 27) or high (n = 6) risks for bias in the key domains assessed. CONCLUSIONS AND RELEVANCE: Pain management is a neglected outcome in randomized clinical trials of mandibular trauma; most studies did not describe the specific analgesics used. Many randomized clinical trials (13 [34%]) assessed pain levels among patients without providing information about the agents prescribed. The incorporation of validated pain measures and quality-of-life scores in future studies of mandibular trauma would focus attention on this key outcome measure.