A new paracetamol/paracetamol-methionine ester combination effects on postoperative course
Abstract
The SUR2647 combination is a sachet formulation containing free paracetamol and its N-acetyl-methionate ester (SUR2647). In a randomized, single-blind, within-patient study the effect of the SUR2647 combination on the postoperative course was investigated in 30 out-patients after bilateral oral surgery. On one occasion they received sachets of SUR2647 combination 2 b.i.d. (equivalent to 2 g paracetamol X 2) on the day of operation, and one sachet b.i.d. (equivalent to 1 g paracetamol X 2) on the following two days. On the other occasion they received placebo caplets. The observed mean reduction in swelling on the third (16%) and seventh (34%) postoperative days after receiving active drug was not significantly different as compared to placebo, nor was there a significant difference between the two treatments with respect to oral temperature, mouth-opening capability or postoperative bleeding. Pain after the SUR2647 combination regime was significantly lower (P less than 0.01) than placebo until the second postoperative evening. Complaints were registered in both treatment groups, although reports of mild to moderate drowsiness were more common after the SUR2647 combination.
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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