Children with simple fractures require adequate pain relief after discharge from the emergency department (ED). Although ibuprofen potentially provides similar pain relief as opioids, ED practices vary widely, and limited data are available comparing the 2 analgesics.
This is a randomized, double-blind controlled trial of children presenting with simple arm fracture to ED during 4 years to compare the efficacy of ibuprofen vs acetaminophen with codeine on outpatient pain relief, function, and satisfaction.
Included were children aged 4 to 18 years weighing less than 60 kg presenting to a level I hospital ED within 12 hours of injury (2003-2007) with a fracture of the ulna, radius, or humerus visualized on a standard 2-view radiograph with fracture diagnosis confirmed by a pediatric radiologist. Excluded were children with an isolated posterior fat pad of the elbow, open fractures, and those who required manipulation or reduction in the ED, with developmental delay, chronic illness, allergy to the medications, or a history of bleeding or gastrointestinal tract disorders. All treatment decisions were made by board-certified emergency pediatricians and fellows; patients received usual care including splinting by ED personnel and analgesia in the ED. Primary outcome was failure of pain relief, defined as use of rescue medication. Secondary outcomes were pain relief, pain medication use, pain scores, functional outcomes, and adverse effects. Outcomes were collected in a diary given to parents and returned in a stamped, addressed envelope with 2 telephone calls made in the first 72 hours after discharge from the ED to remind parents. Ibuprofen suspension was dosed at 10 mg/kg (100 mg/5 mL) and acetaminophen with codeine at 1 mg/kg (120 mg/5 mg per 5 mL) of the codeine content, with a maximum of 4 permitted doses in 24 hours. The medications were matched for color and volume but not taste. Parents were instructed to use the rescue medication if pain was not relieved (pain score ≥ 3) 1 hour after dosing of the study medication. The modified Bieri Faces Pain Scale was the validated pain scale used for assessment by parents; children were assessed at awakening, bedtime, and before and at 1 hour after each dose. Daily total, median, maximal, and minimum scores were collected. Parent satisfaction was recorded daily with a Likert scale, and the Total Quality Pain Management instrument was used for parent and child on day 3. 167 children were assigned to acetaminophen with codeine and 169 to ibuprofen, with a follow-up of 75% for acetaminophen with codeine and 78% for ibuprofen. 244 children were included in the analysis after some were ineligible or lost to follow-up (116 in the acetaminophen/codeine group and 128 in the ibuprofen group). Mean age was 8 years, half were boys, mean weight was 28 kg, 75% were white, and 9.5% to 14.1% were black. Half were radius-only fractures, and one fifth involved the radius and ulna. There were no significant differences in the number of doses of medication received 3 days after ED discharge, and only 7% of children used no medication. The difference in failure of medication was not significant between the ibuprofen group (20.3%) and the acetaminophen with codeine group (31.0%). There were no differences in total pain scores for days 0 to 3 including scores at awakening, bedtime, and before and after medication. For functional outcomes, ibuprofen was significantly superior in return to play and eating but not for return to school and sleep functions. 60% of children had at least 1 function affected on the day of injury and 29.4% by day 3. The risk for an adverse effect was significantly greater in the acetaminophen with codeine group (50.9%) than the ibuprofen group (29.5%). Nausea and vomiting were significantly more common in the acetaminophen with codeine group. 86% of parents who used ibuprofen vs 67% of those using acetaminophen with codeine were very satisfied or satisfied. 27.5% in the acetaminophen group vs 10% in the ibuprofen group said they would not use the medication again. The authors concluded that ibuprofen was similar in efficacy for pain relief in children with simple arm fracture but superior in return to function and fewer adverse effects and that ibuprofen is preferable in the outpatient management of simple arm fracture.
Ibuprofen is similar to acetaminophen with codeine in efficacy for pain relief in children with simple arm fracture. Ibuprofen is superior to acetaminophen with codeine for return to play and eating and fewer adverse effects in the outpatient management of simple arm fracture.