Analgesia Lasts Longer with Naproxen Than Ibuprofen in Dental Pain

Objectives: Long-lasting pain relief is important to patients, but comparative data regarding the duration of analgesia of non-prescription doses of common non-steroidal anti-inflammatory drugs is insufficient. We compared the duration of pain relief following a maximum single, non-prescription dose of naproxen versus ibuprofen and placebo in subjects with moderate-to-severe dental pain.
Methods: Our 24-h, single-center, randomized, double-blind, parallel, placebo-controlled study was carried out in healthy subjects with moderate-to-severe pain (baseline Categorical Pain Intensity Scale) and a score of ≥5 on a 0-10 pain intensity numerical rating scale within 4.5h post-surgery following extraction of ≥2 impacted mandibular third molars. A single oral dose of naproxen sodium (440mg), ibuprofen (400mg), or placebo was administered. The primary efficacy endpoint was the time to first use of rescue medication; secondary endpoints included pain intensity and pain relief over 24h.
Results: The per protocol (PP) population included 385 subjects (naproxen n=166, ibuprofen n=165, placebo n=54; mean age 19 years). The time to rescue medication was significantly longer with naproxen versus ibuprofen (p<0.001) and placebo (p<0.001). The Kaplan-Meier curve indicated that after treatment, the greatest separation of naproxen from ibuprofen occurred at 9-14h and from placebo at 1-6h. Furthermore, fewer naproxen subjects (34.9%) required rescue medication compared with ibuprofen (83.0%) and placebo (81.5%). The least squares (LS) mean (±standard deviation) sum of pain intensity difference from baseline over 24h was significantly greater with naproxen (83.3±50.58) than ibuprofen (48.6±50.58, p<0.05) and placebo (9.9±50.58, p<0.05). The LS mean total pain relief over 24h was also significantly greater with naproxen (47.2±24.59) than ibuprofen (29.0±24.59, p<0.05) and placebo (13.4±24.59, p<0.05).
Conclusions: The duration of pain relief with a single non-prescription dose of naproxen sodium is significantly longer than that with ibuprofen, and significantly fewer naproxen-treated subjects required rescue medication over a 24-h period.