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A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain. Ann Emerg Med 2009 Oct;54(4):553-60

Date

08/21/2009

Pubmed ID

19692147

DOI

10.1016/j.annemergmed.2009.06.005

Scopus ID

2-s2.0-70349141330 (requires institutional sign-in at Scopus site)   129 Citations

Abstract

STUDY OBJECTIVE: We compare the treatment of pain in children with arm fractures by ibuprofen 10 mg/kg versus acetaminophen with codeine 1 mg/kg/dose (codeine component).

METHODS: This was a randomized, double-blind, clinical trial of children during the first 3 days after discharge from the emergency department (ED). The primary outcome was failure of the oral study medication, defined as use of the rescue medication. Pain medication use, pain scores, functional outcomes, adverse effects, and satisfaction were also assessed.

RESULTS: Three hundred thirty-six children were randomized to treatment, 169 to ibuprofen and 167 to acetaminophen with codeine; 244 patients were analyzed. Both groups used a median of 4 doses (interquartile range 2, 6.5). The proportion of treatment failures for ibuprofen (20.3%) was lower than for acetaminophen with codeine (31.0%), though not statistically significant (difference=10.7%; 95% confidence interval -0.2 to 21.6). The proportion of children who had any function (play, sleep, eating, school) affected by pain when pain was analyzed by day after injury was significantly lower for the ibuprofen group. Significantly more children receiving acetaminophen with codeine reported adverse effects and did not want to use it for future fractures.

CONCLUSION: Ibuprofen was at least as effective as acetaminophen with codeine for outpatient analgesia for children with arm fractures. There was no significant difference in analgesic failure or pain scores, but children receiving ibuprofen had better functional outcomes. Children receiving ibuprofen had significantly fewer adverse effects, and both children and parents were more satisfied with ibuprofen. Ibuprofen is preferable to acetaminophen with codeine for outpatient treatment of children with uncomplicated arm fractures.

Author List

Drendel AL, Gorelick MH, Weisman SJ, Lyon R, Brousseau DC, Kim MK

Authors

Amy L. Drendel DO Interim Chief, Professor in the Pediatrics department at Medical College of Wisconsin
Roger M. Lyon MD Adjunct Professor in the Orthopaedic Surgery department at Medical College of Wisconsin
Steven J. Weisman MD Professor in the Anesthesiology department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Acetaminophen
Adolescent
Analgesics
Arm Injuries
Child
Child, Preschool
Codeine
Double-Blind Method
Drug Combinations
Female
Follow-Up Studies
Fractures, Bone
Humans
Ibuprofen
Interviews as Topic
Male
Pain
Self Administration
Treatment Failure