Background: There is evidence that children and adults presenting to the emergency department (ED) do not receive adequate analgesia for painful soft-tissue and musculoskeletal injuries. One trial studied the use of acetaminophen and nonsteroidal anti-inflammatory drugs in adults and found no difference in pain relief. It is not known in children, however, whether one oral medication is more effective than another when treating musculoskeletal pain in an emergency setting. Clark and colleagues designed this randomized controlled study to determine whether acetaminophen, ibuprofen, or codeine was more effective at controlling pain in children who presented to the ED with soft-tissue or musculoskeletal injuries.
The Study: Children six to 17 years of age who presented to the ED within 48 hours of a musculoskeletal injury were randomized to codeine (Robitussin AC), ibuprofen (Motrin), or acetaminophen. Children were excluded if they had been treated with one of the study drugs within the preceding four to six hours, depending on which medication they had taken; if they had an open fracture, intravenous line placement, or serious cognitive impairment; if they had a contraindication to a study drug; or if they needed to be resuscitated. Study participants were given 15 mg per kg acetaminophen; 10 mg per kg ibuprofen; or 1 mg per kg codeine. At baseline, the patient's pain was assessed by a visual analog score, which was a 100-mm line labeled “no pain” at 0 mm and “worst pain” at 100 mm. Pain also was assessed every 30 minutes for 120 minutes. Children were offered additional doses at 60 minutes and every 30 minutes thereafter. Adverse events were assessed two days later by contacting the parents by phone.
The primary outcome measured was the change in the self-reported visual analog score from baseline to 60 minutes after receiving medication. Secondary outcome measures were change in baseline pain at 30 minutes, 90 minutes, and 120 minutes; the need for additional dosing; and achieving adequate analgesia, which was defined as a score less than 30 mm on the visual analog scale at 60 and 120 minutes.
Results: Of 801 children presenting to the ED, 780 children were eligible and 336 were enrolled in the study. At 30 minutes, pain response was similar in all three groups. After 60 minutes, the patients who were given ibuprofen had superior pain relief that was statistically significant compared with the patients who were given acetaminophen or codeine. There was no difference between the effectiveness of acetaminophen and codeine at any time during the study. At 60 minutes, 52 percent of the children in the ibuprofen group achieved adequate analgesia (i.e., a visual analog score of less than 30 mm) compared with 40 and 36 percent of patients in the codeine and acetaminophen groups, respectively. The percentage of children who required additional analgesia dosing was similar in all groups.
A subgroup analysis showed that ibuprofen provided superior relief for pain resulting from fractures but not from soft-tissue injuries compared with the other study drugs; however, ibuprofen achieved adequate analgesia in these subgroups at 60 minutes and was equivalent to codeine at 120 minutes.
Conclusion: Ibuprofen provided superior pain relief compared with codeine and acetaminophen, especially in children with fracture-related pain, but only 52 percent of the children received adequate pain relief. Additional measures, such as ice or distraction, should be sought to help alleviate acute musculoskeletal pain. When used alone, ibuprofen is not an adequate analgesic in all children with musculoskeletal injuries.