title: Naproxen versus acetaminophen for therapy of soft tissue injuries to the ankle in children.
abstract: 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.
authors.affiliation: Department of Physiology & Pharmacology, University of Western Ontario, London, Ontario, Canada.
authors.forename: Victoria A
authors.initials: VA
authors.lastname: Cukiernik
authors.forename: Rod
authors.initials: R
authors.lastname: Lim
authors.forename: David
authors.initials: D
authors.lastname: Warren
authors.forename: Jamie A
authors.initials: JA
authors.lastname: Seabrook
authors.forename: Doreen
authors.initials: D
authors.lastname: Matsui
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Rieder
mesh_terms: 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*
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D000082:Acetaminophen; D009288:Naproxen