A randomized, double-blind, placebo-controlled comparison of the analgesic efficacy, onset of action, and tolerability of ibuprofen arginate and ibuprofen in postoperative dental pain

Black, Peter M.; Max, Mitchell B.; Desjardins, Paul J.; Norwood, Thomas H.; Ardia, Alfredo; Pallotta, Teresa

doi:10.1016/s0149-2918(02)80020-0

Cited by 56 publications

(48 citation statements)

References 17 publications

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“…[15][16][17] This clinical trial supports the hypothesis that ibuprofen arginate is as efficacious as conventional ibuprofen, but with a faster onset of action. In this study, ibuprofen arginate was shown to have significantly faster pain relief than conventional ibuprofen.…”

Section: Discussionsupporting

confidence: 72%

Analgesia with ibuprofen arginate versus conventional ibuprofen for patients with dysmenorrhea: a crossover trial

Mehlisch¹,

Ardia

Pallotta³

2003

Current Therapeutic Research

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Background: Dysmenorrhea produces painful abdominal cramps that can disrupt the personal lives and productivity of women.Objective: The aim of this study was to compare the analgesic efficacy, including onset and duration of pain relief, peak effect, and total effect, and tolerability of ibuprofen arginate with those of conventional ibuprofen in patients with moderate to severe pain associated with primary dysmenorrhea.Methods: Patients were administered a single dose of ibuprofen arginate (200 or 400 mg), conventional ibuprofen (200 or 400 mg), or placebo during each of 5 menstrual cycles in a single-center, double-blind, randomized, doubledummy, 5-cycle, crossover study. Patients recorded their pain intensity and pain relief at regularly scheduled intervals (10,20, 30, 40, 50, 60, and 90 minutes and 2, 3, 4, 5, and 6 hours) after taking the study medication, and all study observations were recorded in a patient diary. Pain intensity was rated using the following 4-point categoric rating scale: 0 ϭ none, 1 ϭ mild, 2 ϭ moderate, and 3 ϭ severe. Pain relief was rated on a 5-point scale as 0 ϭ none, 1 ϭ a little, 2 ϭ some, 3 ϭ a lot, and 4 ϭ complete relief. Tolerability of ibuprofen arginate was based on a comparison of the incidence of spontaneously reported adverse events in each of the treatment groups.Results: One hundred four patients entered the study. Of these, 81.7% were white; the mean (SD) age was 27.5 (5.0) years. A total of 65.4% of patients reported moderate pain from dysmenorrhea, and the remaining 34.6% reported severe pain; 20.2% of patients did not complete the study. The median time to achieve meaningful pain relief was ϳ30 minutes faster with ibuprofen arginate 400 mg than with either dose of conventional ibuprofen. Tolerability was similar across all treatments.Conclusions: In this study population of patients experiencing acute pain as a result of primary dysmenorrhea, ibuprofen arginate was associated with 327CURRENT THERAPEUTIC RESEARCH effective, tolerable analgesia and a more rapid onset of action than conventional ibuprofen. The faster onset of analgesia may have a role in clinical practice in treating women with dysmenorrhea. A faster onset of action may be important to women whose personal relationships, productivity, or ability to sleep is being adversely affected by pain. (Curr Ther Res Clin Exp. 2003;64:327-337)

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Section: Discussionsupporting

confidence: 72%

Analgesia with ibuprofen arginate versus conventional ibuprofen for patients with dysmenorrhea: a crossover trial

Mehlisch¹,

Ardia

Pallotta³

2003

Current Therapeutic Research

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“…For the primary endpoint, data were available for the time to perceptible relief from three studies using ibuprofen arginate [11,12,19]. These data suggested that the time to perceptible relief would be 9 to 14 min for the two test formulations, assuming a similar onset of action to that of ibuprofen arginate.…”

Section: Sample Size Determinationmentioning

confidence: 99%

“…The formulation used in this study contains 256 mg of the ibuprofen sodium salt, equivalent to 200 mg ibuprofen acid. It is well documented that ibuprofen salts, such as ibuprofen sodium, lysine and arginate, are more rapidly absorbed than formulations of free ibuprofen acid [9], and several studies have shown that faster absorbed formulations lead to faster onset of analgesia [10][11][12]. The salt dissolves rapidly in the gastrointestinal tract, leading to faster absorption.…”

Section: Introductionmentioning

confidence: 99%

“…The model is widely accepted and has a proven record of assay sensitivity (i.e. separating active drugs from each other as well as from placebo) [11,12,[15][16][17][18]. The model is sensitive enough to demonstrate a correlation between plasma levels of ibuprofen and onset of analgesia, with faster absorbed formulations, such as ibuprofen arginate, having a faster clinical response time than standard ibuprofen [11,12,19].…”

Section: Introductionmentioning

confidence: 99%

“…The results from dental pain studies have been widely extrapolated to other general pain conditions, including most common OTC conditions. Onset of analgesic action was assessed using the twostopwatch technique [11,12,19], and pain intensity and pain relief at each of the assessment timepoints were assessed using traditional descriptor scales. Exploratory analyses were conducted to give additional information about the rate of onset of action of the medications and to compare the extent of relief provided by each of the active formulations.…”

Section: Introductionmentioning

confidence: 99%

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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

Daniels

Reader

Berry

et al. 2009

Eur J Clin Pharmacol

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. 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. European Journal of Clinical Pharmacology, Springer Verlag, 2009, 65 (4) AbstractObjective To compare the onset of action and efficacy of sodium ibuprofen (ibuprofen sodium dihydrate) and ibuprofen acid incorporating poloxamer (ibuprofen/poloxamer) with that of acetaminophen and placebo in patients with post-operative dental pain. Methods A double-blind, randomised, placebo-controlled, active comparator, two-centre study assessing the analgesic efficacy of sodium ibuprofen (512 mg, equivalent to 400 mg ibuprofen acid), ibuprofen/poloxamer (containing 400 mg ibuprofen acid and 120 mg poloxamer 407), acetaminophen (1000 mg) and placebo in patients with moderate-to-severe pain after third molar extraction (n= 322). Onset of action was assessed using the two-stopwatch technique, and pain intensity and relief were measured using validated traditional descriptor scales.Results Significantly more patients achieved confirmed perceptible pain relief and meaningful pain relief with sodium ibuprofen (96.3%, P<0.0001) and ibuprofen/ poloxamer (90.0%, P=0.0005) than with acetaminophen (67.5%). The onset of action of both ibuprofen formulations was comparable with that of acetaminophen up to 45 min post-dose; a marked divergence in onset times in favour of the ibuprofen formulations occurred from 45 min onward. Mean values for the area under the pain relief and pain intensity differences curve (0-6 h) were significantly greater for sodium ibuprofen (3.46) and ibuprofen acid (3.49) than for acetaminophen (2.25) (P< 0.001). Other pain relief and pain intensity endpoints favoured both ibuprofen formulations over acetaminophen. Distractibility from pain (6 h) was significantly greater with the ibuprofen formulations than with acetaminophen (P=0.008 for sodium ibuprofen; P=0.03 for ibuprofen/poloxamer). In patients receiving ibuprofen, pain interfered less with daily activities (at 1 and 6 h) than in those receiving acetaminophen (P≤0.015). Both ibuprofen formulations had significantly better mean global assessment scores than acetaminophen (P<0.001). Tolerability profiles of the ibuprofen formulations were comparable with that of acetaminophen. Conclusions Compared with acetaminophen, sodium ibuprofen was associated with significantly greater analgesic efficacy, pain relief in a greater proportion of patients and greater patient satisfaction.

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Single dose oral ibuprofen for acute postoperative pain in adults

Derry

Derry²,

Moore³

et al. 2009

Cochrane Database of Systematic Reviews

116

113

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Background This review updates a 1999 Cochrane review showing that ibuprofen at various doses was effective in postoperative pain in single dose studies designed to demonstrate analgesic efficacy. New studies have since been published. Ibuprofen is one of the most widely used non-steroidal anti-inflammatory (NSAID) analgesics both by prescription and as an over-the-counter medicine. Ibuprofen is used for acute and chronic painful conditions. Objectives To assess analgesic efficacy of ibuprofen in single oral doses for moderate and severe postoperative pain in adults. Search methods We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to May 2009. Selection criteria Randomised, double blind, placebo-controlled trials of single dose orally administered ibuprofen (any formulation) in adults with moderate to severe acute postoperative pain. Data collection and analysis Two review authors independently assessed trial quality and extracted data. Pain relief or pain intensity data were extracted and converted into the dichotomous outcome of number of participants with at least 50% pain relief over 4 to 6 hours, from which relative risk and number-needed-to-treat-to-benefit (NNT) were calculated. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals were collected. Main results Seventy-two studies compared ibuprofen and placebo (9186 participants). Studies were predominantly of high reporting quality, and the bulk of the information concerned ibuprofen 200 mg and 400 mg. For at least 50% pain relief compared with placebo the NNT for ibuprofen 200 mg (2690 participants) was 2.7 (2.5 to 3.0) and for ibuprofen 400 mg (6475 participants) it was 2.5 (2.4 to 2.6). The proportion with at least 50% pain relief was 46% with 200 mg and 54% with 400 mg. Remedication within 6 hours was less frequent with higher doses, with 48% remedicating with 200 mg and 42% with 400 mg. The median time to remedication was 4.7 hours with 200 mg and 5.4 hours with 400 mg. Sensitivity analysis indicated that pain model and ibuprofen formulation may both affect the result, with dental impaction models and soluble ibuprofen salts producing better efficacy estimates. Adverse events were uncommon, and not different from placebo. Authors’ conclusions The very substantial amount of high quality evidence demonstrates that ibuprofen is an effective analgesic in treating postoperative pain. NNTs for 200 mg and 400 mg ibuprofen did not change significantly from the previous review even when a substantial amount of new information was added. New information is provided on remedication.

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A randomized, double-blind, placebo-controlled comparison of the analgesic efficacy, onset of action, and tolerability of ibuprofen arginate and ibuprofen in postoperative dental pain

Cited by 56 publications

References 17 publications

Analgesia with ibuprofen arginate versus conventional ibuprofen for patients with dysmenorrhea: a crossover trial

Analgesia with ibuprofen arginate versus conventional ibuprofen for patients with dysmenorrhea: a crossover trial

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

Single dose oral ibuprofen for acute postoperative pain in adults

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