Naproxen versus acetaminophen for therapy of soft tissue injuries to the ankle in children.
BACKGROUND
Musculoskeletal (MSK) ankle injuries cause significant morbidity in ambulatory pediatric populations. No optimal pharmacotherapy is available.


OBJECTIVE
To conduct a randomized, double-blind trial to compare 2 drug therapies for soft tissue injury of the ankle.


METHODS
Patients (N = 77, aged 8-14 y, 61% male) with ankle injuries presenting to a regional pediatric emergency department were assigned to receive either acetaminophen (15 mg/kg 4 times a day) or naproxen (5 mg/kg 4 times a day) in a double-blind fashion on a routine basis for a 5 day period. On days 0 and 7, patients rated their degree of disability and pain on weight bearing using a 10 cm visual analog scale developed for this study. In addition, they were examined by a physician who rated pain, tenderness on palpation, and swelling using a 4 point scale. There were 3 follow-up telephone calls on days 3, 14, and 21. Adherence was evaluated by self-report and pill count.


RESULTS
Both the acetaminophen and naproxen groups had significant improvement in degree of disability and pain from day 0 to day 7. There was no statistically significant difference in outcome between the 2 groups by patient self-evaluation or physician assessment. There also was no significant difference in adverse event rates between the 2 groups, and the majority of patients in both groups felt that the medication was helpful.


CONCLUSIONS
No significant difference in efficacy of pain control or improvement of disability between the naproxen and acetaminophen groups suggests no preferential advantage for naproxen over acetaminophen for MSK injuries when given on a regular basis, with concurrent supportive treatment. Possible differential benefit from intermittent therapy needs to be evaluated among children with ankle injury.
Cukiernik
Victoria A
VA
Department of Physiology & Pharmacology, University of Western Ontario, London, Ontario, Canada.
Lim
Rod
R
Warren
David
D
Seabrook
Jamie A
JA
Matsui
Doreen
D
Rieder
Michael J
MJ
D000082:Acetaminophen / Q000627:therapeutic use*; D000293:Adolescent; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D016512:Ankle Injuries / Q000188:drug therapy*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009288:Naproxen / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy; D017695:Soft Tissue Injuries / Q000188:drug therapy*
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; D009288:Naproxen