Clinical trial · Interventional
Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
Oxycodone or Ibuprofen for Suspected Isolated Forearm Fractures in Pediatric Patients: A Randomized Noninferiority Trial
NCT04523623CI-TRIAL-00081966withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Project canceled for other reason , describe: - Lack of enrollment Project canceled - lack of enrollment
Summary
Brief summary (as posted)
Children presenting to the Emergency Room with the chief complaint of forearm injury and/or pain will be randomized to receive oral Oxycodone or Ibuprofen to control pain.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Forearm Injuries | — | UNRESOLVED | — |
| Pain, Acute | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibuprofen | Drug | Ibuprofen | ALIAS |
| Oxycodone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ibuprofen Group
- description
- To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
- interventionNames
- Drug: Ibuprofen
- type
- EXPERIMENTAL
- label
- Oxycodone Group
- description
- To compare analgesia from ibuprofen to oxycodone in the initial treatment of acute pain in suspected isolated forearm fractures in children.
- interventionNames
- Drug: Oxycodone
Primary outcomes (1)
- measure
- Pain change/difference
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 6 to 17 year old children presenting for care in the St. Louis Children's Hospital Emergency Department 2. Suspected acute (within 24 hours) isolated forearm fracture at the time of initial Triage assessment 3. American Society of Anesthesiologist physical status (ASA-PS) classification of I or II 4. Child with parent or legal guardian. Exclusion Criteria: 1. Multiple injuries 2. Known adverse reaction to either ibuprofen or oxycodone pts with abnormal bones or metabolic conditions that affect bones 3. Administration of any opioid within 2 hours prior to presentation 4. Non-English speaking 5. Foster care, police custody, presenting without legal guardian
References
Publications (8)
- BACKGROUNDIbuprofen or oxycodone? An observational cohort study of post emergency department discharge management of children's fracture pain. Ali S., Drendel A.L., Rosychuk R.J., Le May S., McGrath P., Carleton B., Johnson D.W. Canadian Journal of Emergency Medicine 2016 18 Supplement 1 (S47).
- BACKGROUNDCharney RL, Yan Y, Schootman M, Kennedy RM, Luhmann JD. Oxycodone versus codeine for triage pain in children with suspected forearm fracture: a randomized controlled trial. Pediatr Emerg Care. 2008 Sep;24(9):595-600. doi: 10.1097/PEC.0b013e3181850ca3. PMID 18772726
- BACKGROUNDKircher J, Drendel AL, Newton AS, Dulai S, Vandermeer B, Ali S. Pediatric musculoskeletal pain in the emergency department: a medical record review of practice variation. CJEM. 2014 Nov;16(6):449-57. doi: 10.1017/s1481803500003468. PMID 25358276
- BACKGROUNDChang AK, Bijur PE, Esses D, Barnaby DP, Baer J. Effect of a Single Dose of Oral Opioid and Nonopioid Analgesics on Acute Extremity Pain in the Emergency Department: A Randomized Clinical Trial. JAMA. 2017 Nov 7;318(17):1661-1667. doi: 10.1001/jama.2017.16190. PMID 29114833
- BACKGROUNDIlyas AM, Miller AJ, Graham JG, Matzon JL. A Prospective, Randomized, Double-Blinded Trial Comparing Acetaminophen, Ibuprofen, and Oxycodone for Pain Management After Hand Surgery. Orthopedics. 2019 Mar 1;42(2):110-115. doi: 10.3928/01477447-20190221-02. Epub 2019 Feb 27. PMID 30810754
- BACKGROUNDKelly LE, Sommer DD, Ramakrishna J, Hoffbauer S, Arbab-Tafti S, Reid D, Maclean J, Koren G. Morphine or Ibuprofen for post-tonsillectomy analgesia: a randomized trial. Pediatrics. 2015 Feb;135(2):307-13. doi: 10.1542/peds.2014-1906. PMID 25624387
- BACKGROUNDMoradi M, Esmaeili S, Shoar S, Safari S. Use of oxycodone in pain management. Anesth Pain Med. 2012 Spring;1(4):262-4. doi: 10.5812/aapm.4529. Epub 2012 Apr 1.