A Controlled Comparative Study of Ibuprofen Arginate versus Conventional Ibuprofen in the Treatment of Postoperative Dental Pain

Mehlisch, Donald R.; Ardia, Alfredo; Pallotta, Teresa

doi:10.1177/009127002401102821

Cited by 40 publications

(30 citation statements)

References 11 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: 70%

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: 70%

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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“…In terms of SPRID over 6 h, both ibuprofen test formulations were significantly more efficacious than acetaminophen. Previous studies using the post-operative dental pain model have demonstrated that treatment with a different ibuprofen salt formulation, ibuprofen arginate (l-arginine salt of ibuprofen), resulted in faster onset times to analgesia and greater overall efficacy than treatment with conventional (standard) ibuprofen [11,12,19]. The pharmacokinetic profile of the ibuprofen sodium formulation used in this study has been shown to be similar to that of ibuprofen arginate with peak plasma concentrations achieved at approximately 30-40 min, compared with 1-2 h for standard ibuprofen [8,13,14].…”

Section: Discussionmentioning

confidence: 99%

“…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%

“…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]. The results from dental pain studies have been widely extrapolated to other general pain conditions, including most common OTC conditions.…”

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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Ibuprofen for acute postoperative pain in children

Pessano,

Gloeck,

Tancredi

et al. 2024

Cochrane Database of Systematic Reviews

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A Controlled Comparative Study of Ibuprofen Arginate versus Conventional Ibuprofen in the Treatment of Postoperative Dental Pain

Cited by 40 publications

References 11 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

Ibuprofen for acute postoperative pain in children

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