OTTAWA, Ontario -- For relieving children's pain from acute musculoskeletal injuries, ibuprofen beat out both acetaminophen and codeine, found investigators here.
OTTAWA, Ontario, March 5 -- For relieving children's pain from acute musculoskeletal injuries, ibuprofen beat out both acetaminophen and codeine, found investigators here.
Among 300 children who arrived at the emergency department with pain from a musculoskeletal injury, ibuprofen (Motrin, Advil and generics ) led to significantly better improvement on a pain scale than acetaminophen (Tylenol and generics) or codeine, reported Eric Clark, M.D., of the University of Ottawa, and colleagues.
The injuries to the extremities, neck, or back included fractures, bruises, and sprains, all incurred within the previous 48 hours, the investigators reported in the March issue of Pediatrics.
For analgesia, the children, from the ages of six to 17, were randomly assigned to receive orally 15 mg/kg of acetaminophen, 10 mg/kg of ibuprofen, or 1 mg/kg of codeine. The children, parents, and research assistants were blinded to assignments.
The primary study outcome was the change in pain from baseline to one hour after drug administration, as measured by a 100 mm visual analog scale with 1 = no pain and 100 = the worst pain.
There were no significant differences in pain scores among the three groups at 30 minutes, but from 60 minutes onwards, the patients who had received ibuprofen reported significantly greater pain relief (improvement in pain score) than patients in either the acetaminophen or codeine groups (P<0.001). There were no significant differences at any point between the two latter groups.
The children who received codeine had an 11-point decline in pain scores (95% confidence interval -16 to -5), compared with a 12-point drop in the children who received acetaminophen (95% CI -16 to -8), and a 24-point decline in the kids on ibuprofen (95% CI -29 to -20).
Ibuprofen still provided better pain relief at two hours than either of the other analgesics, and was also significantly better at one hour (but not at two hours) at providing adequate analgesia, defined as a visual analog scale score of less than 30 mm (P<0.001).
Ibuprofen was also significantly better at relieving pain from fractures at both 60 and 120 minutes. There was no statistical difference between codeine and acetaminophen for relief of fracture pain, however.
There were no significant differences in change in pain score among the three drug groups for patients with soft-tissue injuries. When the authors looked only at those patients with pain scores higher than 30 mm at baseline, they found that ibuprofen was significantly better than the other two drugs at the 60- minute but not 120-minute mark.
There were no significant adverse events, except that one child in the codeine group was accidentally administered 5 mg/kg of codeine as a single dose. The child was withdrawn from the study, treated with oral charcoal, monitored in the ED, and had no adverse outcome.
The authors pointed out that "it is also important to note that although ibuprofen was more efficacious in providing adequate analgesia, only 52% of children in this group could be defined as receiving "adequate analgesia" at 60 minutes."
"Although codeine and acetaminophen did result in some improvement in pain, the actual level of improvement (a change of 10-11 mm on the VAS) is only just within the range previous studies have suggested to represent a significant improvement in pain," the authors noted. "Thus, although ibuprofen provided better pain relief than codeine and acetaminophen in our study, it seems that ibuprofen alone is not adequate for relieving pain in all children with musculoskeletal injuries."
The study was limited by a large number of eligible patients who did not participate, although the characteristics of the participants were similar to those who opted out, the authors said. The study also may not have been adequately blinded, they acknowledged, as suggested by the fact about half of patients, parents, and research assistants involved in the study correctly guessed the medication that was given in the acetaminophen and ibuprofen groups.