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

Abstract

. 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.

Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo

“…The favorable safety profile of IBU Na described in this analysis is consistent with that seen in clinical studies of other IBU Na formulations [19][20][21][22][23]. In those studies, AEs associated with IBU Na were typically mild to moderate and did not result in treatment discontinuation.…”

Poloxamer-based binary hydrogels for delivering tramadol hydrochloride: sol-gel transition studies, dissolution-release kinetics, in vitro toxicity, and pharmacological evaluation

“…[12][13][14] Subsequently, other studies presented the preparation and characterization processes of PL 407 hydrogels containing diclofenac, 15 lidocaine, dibucaine, tetracaine, [16][17][18] and bupivacaine 19 as well as their pharmacological evaluations in animal models 17,20,21 and humans. 22,23 However, these formulations were addressed for the use of a single type of PL. Moreover, there are no studies on PL-based in situ thermogelling hydrogel formulations containing TR for subcutaneous injection for the treatment of postoperative pain.…”

Comparison of anti-inflammatory and analgesic effects of Ginger powder and Ibuprofen in postsurgical pain model: A randomized, double-blind, case–control clinical trial

“…Therefore, it is often used as the primary clinical pain model for the investigation of analgesic drugs. [13] Compounds with anti-inflammatory properties provide better analgesia than centrally acting analgesics in this model. [12]…”

“…[13] The efficacy of ibuprofen in the treatment of postoperative dental pain has been demonstrated in several clinical trials. However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions.…”

“…However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. [1314151617] Therefore, there is a need for an effective analgesic with a more favorable safety profile. In the literature, despite high anti-inflammatory potential of ginger constituents, it was used mainly against chronic inflammatory conditions while its effect on acute inflammation was assessed in animal studies and rare clinical trials.…”