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Analgesic efficacy and tolerability of ketoprofen lysine salt vs paracetamol in common paediatric surgery. A randomized, single‐blind, parallel, multicentre trial
Author(s) -
Messeri Andrea,
Busoni Paolo,
Noccioli Bruno,
Murolo Sandro,
Ivani Giorgio,
Grossetti Roberto,
Gallini Carla,
Maestri Luciano,
Fedele Guido,
Novellini Roberto
Publication year - 2003
Publication title -
pediatric anesthesia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.704
H-Index - 82
eISSN - 1460-9592
pISSN - 1155-5645
DOI - 10.1046/j.1460-9592.2003.01089.x
Subject(s) - medicine , ketoprofen , tolerability , analgesic , visual analogue scale , anesthesia , randomized controlled trial , adverse effect , acetaminophen , surgery , pharmacology
Summary Background: In this study, we compared the analgesic efficacy of ketoprofen lysine salt (OKi ® suppositories) vs paracetamol, in children undergoing minor surgery. We also studied the side‐effects of the treatment. Methods: Eighty‐five children of both sexes, aged 6–14 years, were enrolled in a multicentre, randomized, single‐blind, parallel‐group study design. In all patients postsurgical pain was evaluated by visual analogue scale (VAS) and degree of distress (night‐time awakening, crying, behaviour and defence posture). Results: Ketoprofen lysine was more effective than paracetamol in reducing postoperative pain ( P = 0.008) with earlier onset and longer duration (8 h) of the antinociceptive effect. Evaluation of area under the curve, an aggregated measure of VAS, and of distress, confirm the time profile of pain reduction. No adverse effects related to the treatment were observed. Conclusions: Ketoprofen lysine salt can be considered a potent therapeutic approach to control postsurgery pain in children, and an alternative to other established drug regimens.