A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain.
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.


CONCLUSIONS
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.
Drendel
Amy L
AL
Pediatric Emergency Medicine Division, Medical College of Wisconsin, Milwaukee, WI, USA. adrendel@mcw.edu
Gorelick
Marc H
MH
Weisman
Steven J
SJ
Lyon
Roger
R
Brousseau
David C
DC
Kim
Michael K
MK
D000082:Acetaminophen / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D001134:Arm Injuries / Q000150:complications*; D002648:Child; D002675:Child, Preschool; D003061:Codeine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D050723:Fractures, Bone / Q000150:complications*; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects / Q000627:therapeutic use*; D007407:Interviews as Topic; D008297:Male; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D012646:Self Administration; D017211:Treatment Failure
D000700:Analgesics; D004338:Drug Combinations; D000082:Acetaminophen; D003061:Codeine; D007052:Ibuprofen