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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.

AbstractBACKGROUND:
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.
AuthorsAndrea Messeri, Paolo Busoni, Bruno Noccioli, Sandro Murolo, Giorgio Ivani, Roberto Grossetti, Carla Gallini, Luciano Maestri, Guido Fedele, Roberto Novellini
JournalPaediatric anaesthesia (Paediatr Anaesth) Vol. 13 Issue 7 Pg. 574-8 (Sep 2003) ISSN: 1155-5645 [Print] France
PMID12950856 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Analgesics, Non-Narcotic
  • Anti-Inflammatory Agents, Non-Steroidal
  • Acetaminophen
  • ketoprofen lysine
  • Ketoprofen
  • Lysine
Topics
  • Acetaminophen (adverse effects, therapeutic use)
  • Administration, Rectal
  • Adolescent
  • Analgesics, Non-Narcotic (adverse effects, therapeutic use)
  • Anesthesia, Epidural
  • Anti-Inflammatory Agents, Non-Steroidal (adverse effects, therapeutic use)
  • Area Under Curve
  • Child
  • Female
  • Humans
  • Ketoprofen (adverse effects, analogs & derivatives, therapeutic use)
  • Lysine (adverse effects, analogs & derivatives, therapeutic use)
  • Male
  • Minor Surgical Procedures
  • Pain Measurement
  • Pain, Postoperative (diagnosis, prevention & control)
  • Prospective Studies
  • Single-Blind Method
  • Time Factors
  • Treatment Outcome

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