Analgesic efficacy and tolerability of ketoprofen lysine salt vs paracetamol in common paediatric surgery. A randomized, single-blind, parallel, multicentre trial.
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.
Messeri
Andrea
A
Anestesia e Rianimazione Pediatrica, Azienda Ospedaliera A Meyer, Firenze, Italy.
Busoni
Paolo
P
Noccioli
Bruno
B
Murolo
Sandro
S
Ivani
Giorgio
G
Grossetti
Roberto
R
Gallini
Carla
C
Maestri
Luciano
L
Fedele
Guido
G
Novellini
Roberto
R
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
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; C029946:ketoprofen lysine; D007660:Ketoprofen; D008239:Lysine