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Quantifying the intensity of adverse events with ibuprofen and oxycodone: an observational cohort study
Samina Ali1,2, Katie Gourlay3, Aran Yukseloglu4
1Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada sali@ualberta.ca.
Insights
Oxycodone use in children with fractures led to more frequent and intense side effects, including nausea and drowsiness, compared to ibuprofen. This suggests ibuprofen may be a preferable option for pediatric fracture pain management.
Area of Science:
- Pediatric Emergency Medicine
- Pain Management
- Pharmacovigilance
Background:
- Acute fractures are common in children, necessitating effective pain management.
- Opioid analgesics like oxycodone are potent but carry risks of adverse events (AEs).
- Non-opioid alternatives such as ibuprofen offer a different safety and efficacy profile.
Purpose of the Study:
- To compare the frequency and intensity of adverse events (AEs) in children treated with ibuprofen versus oxycodone for acute fracture pain.
- To assess functional outcomes and identify factors associated with AEs in pediatric fracture patients.
Main Methods:
- An observational cohort study was conducted in a pediatric emergency department.
- 240 children (aged 4-16 years) with acute fractures were analyzed.
- AEs and functional outcomes (eating, sleeping, playing, school attendance) were monitored for 3 days post-discharge via phone calls.
Main Results:
- Oxycodone use was linked to significantly higher rates of AEs, including nausea, vomiting, drowsiness, and constipation, compared to ibuprofen.
- Children on oxycodone experienced more severe abdominal pain and constipation.
- Factors associated with missed school included higher pain scores, lower extremity fractures, and ED sedation.
Conclusions:
- Oxycodone is associated with a greater burden of AEs and functional limitations in children with fractures compared to ibuprofen.
- Lower extremity fractures contribute to more significant functional impairments.
- These findings support careful consideration of analgesic choice in pediatric fracture care.
Objective:
To quantify the frequency and intensity of adverse events (AEs), commonly known as side effects, experienced by children receiving either ibuprofen or oxycodone for pain management following an acute fracture. Secondary objectives were to quantify functional outcome impairment and describe demographic and clinical characteristics associated with AEs.
Design:
Observational cohort study.
Setting:
Paediatric emergency department.
Patients:
Patients (n=240) aged 4-16 years diagnosed with an acute fracture.
Intervention:
Prescribed either ibuprofen (n=179) or oxycodone (n=61) for pain.
Main Outcome Measures:
Families were called for the first 3 days after discharge to report the presence and intensity of AEs and their child's functional outcomes (ability to eat, sleep, play or attend school).
Results:
On day 1, children using oxycodone were more likely to report any AE (χ2 1=13.5, p<0.001), nausea (χ2 1=17.0, p<0.001), vomiting (χ2 1=11.2, p<0.001), drowsiness (χ2 1=13.7,p<0.001), constipation (χ2 1=8.9, p=0.003) and dizziness (χ2 1=19.1, p<0.001), compared with those using ibuprofen. Children receiving oxycodone reported greater severity of abdominal pain (oxycodone: mean 5.4 SD 3.1; ibuprofen mean 2.5 SD 1.4, F1 13=6.5, p=0.02) on day 1 and worse intensity of constipation (oxycodone: mean 4.9 SD 2.1; ibuprofen mean 3.2 SD 2.2, F1 33=4.5, p=0.04) over all 3 days. Use of oxycodone was associated with an increased odds of experiencing an AE on day 1 (OR=1.31 (95% CI 1.13 to 1.52)). Higher pain scores (OR=1.50 (95% CI 1.12 to 2.01)), lower extremity fracture (OR=1.25 (95% CI 1.07 to 1.47)) and undergoing ED sedation (OR=1.16 (95% CI 1.01 to 1.34)) were associated with missing school. Higher pain scores (OR=1.50 (95% CI 1.14 to 1.97)) and lower extremity fractures (OR=1.23 (95% CI 1.07 to 1.43)) were also associated with less play.
Conclusions:
Oxycodone is associated with more frequent AEs overall, higher intensity gastrointestinal AEs and greater functional limitations compared with ibuprofen. Lower extremity fractures cause more functional limitations than upper extremity fractures. Clinicians should consider these differences when providing fracture pain care for children.
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