Naproxen versus Acetaminophen for Therapy of Soft Tissue Injuries to the Ankle in Children ^(September)

¹ Research Associate, Department of Physiology & Pharmacology, University of Western Ontario; Division of Clinical Pharmacology, Children's Hospital of Western Ontario, London, Ontario, Canada
² Assistant Professor, Departments of Paediatrics and Medicine, University of Western Ontario; Division of Emergency Paediatrics, Children's Hospital of Western Ontario
³ Associate Professor, Departments of Paediatrics and Medicine, University of Western Ontario; Division of Emergency Paediatrics, Children's Hospital of Western Ontario
⁴ Research Associate, Department of Paediatrics, University of Western Ontario; Children's Hospital of Western Ontario
⁵ Associate Professor, Departments of Paediatrics and Medicine, University of Western Ontario; Division of Clinical Pharmacology, Children's Hospital of Western Ontario
⁶ GSKCIHR Chair in Paediatric Clinical Pharmacology, Departments of Paediatrics, Physiology & Pharmacology, and Medicine, University of Western Ontario; Division of Emergency Paediatrics, Children's Hospital of Western Ontario

^* To whom correspondence should be addressed. E-mail: mrieder{at}uwo.ca.

	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.

Key Words: acetaminophen, musculoskeletal injury, naproxen, pediatrics.

Reprints: Dr. Rieder, Division of Clinical Pharmacology, Children's Hospital of Western Ontario, 800 Commissioners Rd. E, London, Ontario, Canada N6C 2V5, fax 519/685-8156, mrieder@uwo.ca