Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen

Abstract

Objectives: A novel, immediate-release tablet formulation of ibuprofen (IBU) sodium dihydrate, Advil Film Coated Tablets (IBUNa), has been developed that is absorbed faster than standard IBU tablets. The objective of the current study was to compare the efficacy and onset of analgesia of this new formulation with standard IBU tablets after a single dose.

Materials and methods: Patients (N=316) with at least moderate baseline postsurgical dental pain were randomized to 400 mg IBUNa, Advil (IBUAdv), Motrin (IBUMot), or placebo. Primary endpoints were time-weighted sum of pain relief (PR) and pain intensity differences over 8 hours (SPRID 0-8) and time to onset of meaningful pain relief (TMPR) measured by the double-stopwatch method.

Results: SPRID 0-8 was significantly greater for IBUNa and the other active treatments versus placebo (P<0.001). IBUNa had a significantly earlier TMPR versus placebo, pooled IBUAdv/IBUMot, and IBUMot (P<0.001 for all), and a marginally faster TMPR (P=0.075) versus IBUAdv. Results for secondary endpoints were similar. Adverse events were comparable across treatment groups, with gastrointestinal disorders being most frequently reported. Most adverse events were mild or moderate.

Discussion: This novel formulation of IBUNa provided superior overall PR compared with placebo and more rapid onset of analgesic effect compared with standard IBU tablets. Rapid PR is important in the treatment of acute pain, including dental pain, and this IBUNa formulation represents a new treatment option for rapid PR.

Trial registration: ClinicalTrials.gov NCT01098747.

FIGURE 1

Time to meaningful pain relief. Per protocol, the comparisons of pooled IBU_Adv/IBU_Mot versus placebo and IBU_Adv versus IBU_Mot were not performed. ^aP≤0.001 versus placebo. ^bP≤0.001 versus pooled IBU_Adv/IBU_Mot. ^cP≤0.001 versus IBU_Mot. IBU_Adv indicates Advil; IBU_Mot, Motrin; IBU_Na, Advil Film Coated Tablets.

FIGURE 2

Pain relief rating combined with pain intensity difference (PRID) scores over time. Per protocol, the comparisons of pooled IBU_Adv/IBU_Mot versus placebo and IBU_Adv versus IBU_Mot were not performed. ^aP≤0.001 versus placebo. ^bP≤0.01 versus placebo. ^cP≤0.001 versus pooled IBU_Adv/IBU_Mot. ^dP≤0.01 versus pooled IBU_Adv/IBU_Mot. ^eP≤0.05 versus pooled IBU_Adv/IBU_Mot. ^fP≤0.001 versus IBU_Adv. ^gP≤0.01 versus IBU_Adv. ^hP≤0.05 versus IBU_Adv. ⁱP≤0.001 versus IBU_Mot. ^jP≤0.01 versus IBU_Mot. ^kP≤0.05 versus IBU_Mot. ^lP≤0.05 versus IBU_Na. IBU_Adv indicates Advil; IBU_Mot, Motrin; IBU_Na, Advil Film Coated Tablets; PRID, sum of pain intensity difference and pain relief rating.

FIGURE 3

Two-, 3-, 6-, and 8-hour summary efficacy measures. Per protocol, the comparisons of pooled IBU_Adv/IBU_Mot versus placebo and IBU_Adv versus IBU_Mot were not performed. ^aP≤0.001 versus placebo. ^bP≤0.01 versus pooled IBU_Adv/IBU_Mot. ^cP≤0.05 versus IBU_Adv. ^dP≤0.01 versus IBU_Mot. IBU_Adv indicates Advil; IBU_Mot, Motrin; IBU_Na, Advil Film Coated Tablets: ibuprofen sodium; SPID, time-weighted sum of pain intensity difference; SPRID, time-weighted sum of pain relief and pain intensity difference; TOTPAR, time-weighted sum of pain relief.

FIGURE 4

Global evaluation of study treatment. ^aP≤0.001 versus placebo. IBU_Adv indicates Advil; IBU_Mot, Motrin; IBU_Na, Advil Film Coated Tablets: ibuprofen sodium.