title: Analgesic efficacy and tolerability of ketoprofen lysine salt vs paracetamol in common paediatric surgery. A randomized, single-blind, parallel, multicentre trial.
abstract: 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.
authors.affiliation: Anestesia e Rianimazione Pediatrica, Azienda Ospedaliera A Meyer, Firenze, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Messeri
authors.forename: Paolo
authors.initials: P
authors.lastname: Busoni
authors.forename: Bruno
authors.initials: B
authors.lastname: Noccioli
authors.forename: Sandro
authors.initials: S
authors.lastname: Murolo
authors.forename: Giorgio
authors.initials: G
authors.lastname: Ivani
authors.forename: Roberto
authors.initials: R
authors.lastname: Grossetti
authors.forename: Carla
authors.initials: C
authors.lastname: Gallini
authors.forename: Luciano
authors.initials: L
authors.lastname: Maestri
authors.forename: Guido
authors.initials: G
authors.lastname: Fedele
authors.forename: Roberto
authors.initials: R
authors.lastname: Novellini
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects / Q000627:therapeutic use*; D000285:Administration, Rectal; D000293:Adolescent; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects / Q000627:therapeutic use*; D000767:Anesthesia, Epidural; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D002648:Child; D005260:Female; D006801:Humans; D007660:Ketoprofen / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008239:Lysine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008297:Male; D013511:Minor Surgical Procedures; D010147:Pain Measurement; D010149:Postoperative Pain / Q000175:diagnosis / Q000517:prevention & control; D011446:Prospective Studies; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; C029946:ketoprofen lysine; D007660:Ketoprofen; D008239:Lysine