2025-11-04 ラトガース大学
<関連情報>
- https://www.rutgers.edu/news/non-prescription-pain-meds-work-equally-well-men-and-women-after-tooth-extraction
- https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2841046
第三大臼歯手術後の男女における鎮痛効果の違い OARSランダム化臨床試験のサブグループ解析 Analgesic Differences in Males and Females After Third Molar Surgery A Subgroup Analysis of the OARS Randomized Clinical Trial
Janine Fredericks-Younger, DMD; Tracy Andrews, MS; Shou-En Lu, PhD;et al
JAMA Network Open Published:November 6, 2025
DOI:10.1001/jamanetworkopen.2025.42467
Introduction
Sex differences in pain are shaped by a range of biological, psychological, and social factors,1 with evidence that women often report greater postsurgical pain2,3 and lower pain thresholds and tolerance.4 To explore potential variation in pain experience and treatment response, the Opioid Analgesic Reduction Study (OARS)5,6 incorporated sex stratification. A prespecified subgroup analysis was conducted to evaluate noninferiority of nonopioids for pain and examined treatment effects on satisfaction and other secondary outcomes between nonopioid and opioid groups within male and female participants separately.
Methods
Rutgers University Institutional Review Board approved the OARS randomized clinical trial, which includes this subgroup analysis, which is reported following the CONSORT reporting guideline. Participants provided written informed consent. OARS, a multisite, noninferiority trial, compared analgesic effectiveness of a nonopioid combination (ibuprofen 400 mg and acetaminophen 500 mg) with an opioid (hydrocodone 5 mg and acetaminophen 300 mg) for postoperative pain management after impacted mandibular third molar extraction (eMethods in Supplement 1; study protocol in Supplement 2).5 Healthy adult participants were randomized by sex and site to receive blinded study analgesic and completed twice-daily electronic diaries postoperatively (eFigure in Supplement 1). A follow-up visit included a clinical exam and survey. Primary outcomes were pain experience and medication satisfaction. Secondary outcomes included sleep quality, pain interference, rescue medication, and adverse events. The noninferiority margin for pain experience was 1.0 points in an 11-point numeric rating scale. Superiority was assessed after establishing noninferiority. Conventional (not noninferiority) testing was used for all other outcomes. Analyses were performed using SAS version 9.4 (SAS Institute). For each outcome, statistical significance was defined by α = .025 (2-sided) for each sex after Bonferroni adjustment to control the overall α of .05, with further adjustments to control for multiple comparisons as appropriate.
Results
Among 1815 participants (mean [SD] age, 25.7 [6.2] years; 50.1% female; 15.0% Asian, 28.2% Black, 30.9% Hispanic, and 19.7% White), 909 received a nonopioid combination and 906 received an opioid. Sex distribution and baseline and surgical characteristics were comparable across groups (Table 1).
