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Clinical Journal of Pain:
doi: 10.1097/AJP.0000000000000142
Original Article: PDF Only

Onset of Analgesia and Efficacy of Ibuprofen Sodium in Postsurgical Dental Pain: A Randomized, Placebo-Controlled Study versus Standard Ibuprofen.

Brain, Patrick DDS; Leyva, Rina MS; Doyle, Geraldine PhD; Kellstein, David PhD

Open Access
Published Ahead-of-Print
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Abstract

Objectives: A novel, immediate-release tablet formulation of ibuprofen sodium dihydrate, Advil(R) 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.

Methods: Subjects (N=316) with at least moderate baseline postsurgical dental pain were randomized to 400 mg IBUNa, Advil(R) (IBUAdv), Motrin(R) (IBUMot), or placebo. Primary endpoints were time-weighted sum of pain relief 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 pain relief compared with placebo and more rapid onset of analgesic effect compared with standard IBU tablets. Rapid pain relief is important in the treatment of acute pain, including dental pain, and this IBUNa formulation represents a new treatment option for rapid pain relief.

This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivitives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/3.0.

(C) 2014 by Lippincott Williams & Wilkins

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