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A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain
Amy L Drendel1, Marc H Gorelick, Steven J Weisman
1Pediatric Emergency Medicine Division, Medical College of Wisconsin, Milwaukee, WI, USA. adrendel@mcw.edu
Insights
Ibuprofen is a better choice than acetaminophen with codeine for treating arm fracture pain in children after they leave the emergency department. It led to better functional outcomes and fewer side effects, with higher satisfaction rates.
Area of Science:
- Pediatric Emergency Medicine
- Pharmacology
- Pain Management
Background:
- Effective pain management is crucial for children with fractures.
- Outpatient analgesia choices for pediatric arm fractures require careful consideration.
- Comparing common pain relievers like ibuprofen and acetaminophen with codeine is important for clinical practice.
Purpose of the Study:
- To compare the efficacy and safety of ibuprofen versus acetaminophen with codeine for treating pain in children with arm fractures after emergency department discharge.
- To evaluate analgesic failure rates, pain scores, functional outcomes, and adverse effects.
Main Methods:
- A randomized, double-blind clinical trial was conducted.
- Participants were children treated within the first 3 days after discharge from the emergency department.
- Outcomes included medication failure, pain scores, functional status, adverse events, and patient satisfaction.
Main Results:
- Ibuprofen showed a lower (though not statistically significant) treatment failure rate compared to acetaminophen with codeine.
- Children receiving ibuprofen experienced significantly better functional outcomes (play, sleep, eating, school).
- Adverse effects were reported less frequently with ibuprofen, and satisfaction was higher among children and parents.
Conclusions:
- Ibuprofen is at least as effective as acetaminophen with codeine for outpatient analgesia in pediatric arm fractures.
- Ibuprofen offers advantages in functional outcomes and safety profile.
- Ibuprofen is recommended as a preferable option over acetaminophen with codeine for the outpatient management of uncomplicated pediatric arm fractures.
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.
