PMID- 36053661 OWN - NLM STAT- MEDLINE DCOM- 20220908 LR - 20220910 IS - 2399-9772 (Electronic) IS - 2399-9772 (Linking) VI - 6 IP - 1 DP - 2022 May TI - Quantifying the intensity of adverse events with ibuprofen and oxycodone: an observational cohort study. LID - 10.1136/bmjpo-2022-001428 [doi] LID - e001428 AB - 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 (chi(2) (1)=13.5, p<0.001), nausea (chi(2) (1)=17.0, p<0.001), vomiting (chi(2) (1)=11.2, p<0.001), drowsiness (chi(2) (1)=13.7,p<0.001), constipation (chi(2) (1)=8.9, p=0.003) and dizziness (chi(2) (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, F(1) (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, F(1) (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. CI - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Ali, Samina AU - Ali S AUID- ORCID: 0000-0002-0595-364X AD - Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada sali@ualberta.ca. AD - Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada. FAU - Gourlay, Katie AU - Gourlay K AD - Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada. FAU - Yukseloglu, Aran AU - Yukseloglu A AD - Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada. FAU - Rosychuk, Rhonda J AU - Rosychuk RJ AD - Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada. AD - Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada. FAU - Ortiz, Silvia AU - Ortiz S AD - Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada. FAU - Watts, Rick AU - Watts R AD - Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada. AD - Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada. FAU - Johnson, David W AU - Johnson DW AD - Department of Pediatrics, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada. FAU - Carleton, Bruce AU - Carleton B AD - Division of Translational Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada. FAU - Le May, Sylvie AU - Le May S AD - Faculty of Nursing, Universite de Montreal, Montreal, Quebec, Canada. FAU - Drendel, Amy L AU - Drendel AL AD - Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA. LA - eng PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20220524 PL - England TA - BMJ Paediatr Open JT - BMJ paediatrics open JID - 101715309 RN - 0 (Analgesics, Opioid) RN - CD35PMG570 (Oxycodone) RN - WK2XYI10QM (Ibuprofen) SB - IM MH - Analgesics, Opioid/adverse effects MH - Child MH - Cohort Studies MH - Constipation/chemically induced MH - Double-Blind Method MH - *Fractures, Bone/chemically induced MH - Humans MH - Ibuprofen/adverse effects MH - *Oxycodone/adverse effects MH - Pain/drug therapy MH - Pain Measurement/adverse effects PMC - PMC9131055 OTO - NOTNLM OT - Analgesia OT - Pain OT - Therapeutics COIS- Competing interests: None declared. EDAT- 2022/09/03 06:00 MHDA- 2022/09/09 06:00 PMCR- 2022/05/23 CRDT- 2022/09/02 11:54 PHST- 2022/01/25 00:00 [received] PHST- 2022/04/19 00:00 [accepted] PHST- 2022/09/02 11:54 [entrez] PHST- 2022/09/03 06:00 [pubmed] PHST- 2022/09/09 06:00 [medline] PHST- 2022/05/23 00:00 [pmc-release] AID - 10.1136/bmjpo-2022-001428 [pii] AID - bmjpo-2022-001428 [pii] AID - 10.1136/bmjpo-2022-001428 [doi] PST - ppublish SO - BMJ Paediatr Open. 2022 May;6(1):e001428. doi: 10.1136/bmjpo-2022-001428. Epub 2022 May 24.