Onset of Analgesia for Liquigel Ibuprofen 400 mg, Acetaminophen 1000 mg, Ketoprofen 25 mg, and Placebo in the Treatment of Postoperative Dental Pain

Abstract

Ibuprofen is a peripherally acting nonsteroidal anti-inflammatory drug indicated fo ranalgesia, antipyresis, and various arthritic conditions. A solubilized 200 mg liquigel formulation of ibuprofen has been shown to have a more rapid rate of absorption compared with ibuprofen 200 mg tablets. Ibuprofen liquigels have a kinetic profile similar to ibuprofen suspension, with both a higher Cmax and an earlier tmax than any solid tablet. The objective of this single-dose, double-blind, triple-dummy, parallel-group study was to assess the time to onset of relief and overall analgesic efficacy of liquigel ibuprofen 400 mg, ketoprofen 25 mg compared with acetaminophen 1000 mg, and placebo in 239 patients with moderate or severe pain following third molar extractions. Treatments were compared over 6 hours using standard scales for pain intensity and relief and stopwatch onset of meaningful relief. All active treatments provided meaningful relief significantly faster compared with placebo. Ibuprofen provided significantly faster relief compared with acetaminophen and ketoprofen. By the end of the study (6 h), onset of meaningful relief was achieved by 36%, 99%, 96%, and 88% of the patients in the placebo, ketoprofen, ibuprofen, and acetaminophen groups, respectively. The median times to onset of relief were > 6 hours for placebo, 25.5 minutes for ketoprofen, 24.2 minutes for ibuprofen, and 29.9 minutes for acetaminophen. In addition, both ibuprofen and ketoprofen showed statistical superiority over acetaminophen at earlier time points on the time-effect curves for pain relief and pain intensity difference. Consistent results were seen with respect to the 6-hour summary efficacy variables: the three active treatments were significantly better than placebo, and ibuprofen was significantly better than both acetaminophen and ketoprofen. Liquigel ibuprofen 400 mg was shown to provide faster relief and superior overall efficacy compared with ketoprofen 25 mg, acetaminophen 1000 mg, and placebo. No serious adverse effects were reported in this single-dose study.

Onset of analgesia with sodium ibuprofen, ibuprofen acid incorporating poloxamer and acetaminophen—a single-dose, double-blind, placebo-controlled study in patients with post-operative dental pain

“…Measures of analgesic duration-the proportion of patients taking rescue medication and the time to rescue medication-showed that those in the acetaminophen group received rescue medication sooner than those in either of the two ibuprofen groups. This suggests that both ibuprofen formulations had a longer duration of action than acetaminophen, which is in keeping with that previously reported for ibuprofen lysine [22] and ibuprofen liquigel [23]. In terms of pain relief and PID, the timepoint at which a significant difference was first observed between either of the ibuprofen formulations and placebo was 15 min (sodium ibuprofen); a significant difference between either of the ibuprofen formulations and acetaminophen was first observed at 45 min (sodium ibuprofen).…”

“…In terms of pain relief and PID, the timepoint at which a significant difference was first observed between either of the ibuprofen formulations and placebo was 15 min (sodium ibuprofen); a significant difference between either of the ibuprofen formulations and acetaminophen was first observed at 45 min (sodium ibuprofen). In comparison with previously published data, studies with ibuprofen arginate and ibuprofen lysine demonstrated significant differences in pain relief and PID between ibuprofen and placebo at 10-15 min [11,12,19,23]. Furthermore, significant differences between ibuprofen lysine and acetaminophen were observed at 15 min, much sooner than the 45 min observed in our study [22].…”

“…For the area under the curve (AUC) (pain relief intensity difference [PRID] from 0 to 6 h), data were available from two previous studies which compared ibuprofen lysine [22] and liquigel [23] ibuprofen with acetaminophen. In the former study, PRID to 6 h was not provided, but the sum of pain intensity differences (SPID) to 6 h was given.…”

An Evidence-Based Update on Nonsteroidal Anti-Inflammatory Drugs

“…Ibuprofen lysine 400 mg produces faster onset and higher peak analgesia than a conventional tablet of ibuprofen acid 400 mg in dental pain. 29 Solubilized liquigel ibuprofen 400 mg had more rapid onset than acetaminophen 1000 mg and had a longer duration of action than either acetaminophen 1000 mg or ketoprofen 25 mg. 30 These differences can be clinically important as the median time to clinically meaningful relief of pain was shorter after solubilized ibuprofen 400 mg than after acetaminophen 1000 mg. 31 The solubilized potassium liquigel formulation of ibuprofen is available over-the-counter worldwide. Diclofenac sodium softgel has also been shown to provide a very rapid onset of analgesic activity and prolonged analgesic duration compared with conventional diclofenac potassium.…”

Content Analysis of False and Misleading Claims in Television Advertising for Prescription and Nonprescription Drugs

“…53 The DERP reviews are updated at least annually, and are subject to peer review and public comment before final publication. 54 These sources were sufficient for evaluating most claims, but for six claims, the coders were provided with additional references: publications from head-to-head trials comparing acetaminophen to ibuprofen, [55][56][57][58][59][60][61] IMS Health data from 2008 to evaluate a claim of prescription popularity, 62 nonprescription label information for a discontinued product from an archived web page, 63,64 links to specific nonprescription drug product labels to evaluate the incipient ingredients in the product, 65,66 and a press release providing up-to-date information to support an advertising claim. 67 We only used publicly available evidence to evaluate claims and did not make requests to pharmaceutical companies for unpublished or "on-file" evidence.…”