Longer analgesic effect with naproxen sodium than ibuprofen in post-surgical dental pain: a randomized, double-blind, placebo-controlled, single-dose trial

<b>Background:</b> Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as first-line medications in mild-to-moderate acute pain. However, comparative data regarding the duration of analgesia for commonly-used NSAIDs at non-prescription doses is lacking. This study evaluated the time to rescue medication following a single dose of naproxen sodium (NAPSO) vs ibuprofen (IBU) and placebo in subjects with moderate-to-severe post-surgical dental pain. <b>Methods:</b> This single-center, randomized, double-blind, parallel group, placebo-controlled study included healthy subjects with moderate-to-severe baseline pain (Categorical Pain Intensity Scale) who also rated their pain ≥ 5 on a 0–10 pain intensity Numerical Rating Scale following extraction of two impacted mandibular third molars. A single oral dose of NAPSO (440 mg), IBU (400 mg), or placebo was administered. The primary efficacy endpoint was the time to first rescue medication, while secondary endpoints included the sum of pain intensity difference (SPID) and total pain relief (TOTPAR) over 24 h. ClinicalTrials.gov trial registration number: NCT03404206 (EudraCT 2017-005049-67). <b>Results:</b> In the per protocol population (<i>n</i> = 385; mean age = 19 years), the time to rescue medication was significantly (<i>p</i> <b>Conclusions:</b> The duration of pain relief after a single dose of NAPSO was significantly longer than after IBU, and significantly fewer NAPSO-treated subjects required rescue medication over a 24-h period. <b>Trial registration:</b>ClinicalTrials.gov identifier: NCT03404206.

**背景：** 非甾体抗炎药（Non-steroidal anti-inflammatory drugs，NSAIDs）是轻中度急性疼痛的一线推荐用药。然而，目前尚无针对常用非处方剂量非甾体抗炎药的镇痛持续时间的对比研究数据。本研究针对中重度术后牙科疼痛受试者，评估单次给予萘普生钠（NAPSO）、布洛芬（IBU）与安慰剂后首次解救用药的时间。
**方法：** 本研究为单中心、随机、双盲、平行组、安慰剂对照试验，纳入基线疼痛为中重度（采用分类疼痛强度量表评估）且在拔除2颗下颌阻生第三磨牙后，于0~10数字疼痛强度量表评分≥5分的健康受试者。受试者单次口服给予NAPSO（440mg）、IBU（400mg）或安慰剂。主要疗效终点为首次解救用药时间，次要疗效终点包括24小时内疼痛强度差值总和（SPID）与总疼痛缓解评分（TOTPAR）。本研究在ClinicalTrials.gov的注册号为NCT03404206（EudraCT注册号：2017-005049-67）。
**结果：** 在符合方案集人群（n=385；平均年龄19岁）中，首次解救用药时间的差异具有统计学意义（*p*
**结论：** 单次给药后，萘普生钠的疼痛缓解持续时间显著长于布洛芬，且24小时内需接受解救用药的萘普生钠组受试者人数显著更少。
**试验注册：** ClinicalTrials.gov注册号：NCT03404206。