drugset / Trial / NCT05640674
Post-operative Pain Management in Children With Supracondylar Humerus Fractures
RandomizedParallel-groupOpen-labelSupportive care
Summary
There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.
Timeline
- Start
- 2023-09-12
- Primary completion
- 2025-12-15
- Completion
- 2025-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 15 mg/kg | — |
| Comparator | Hydrocodone | Unknown | 0.135 mg/kg | — |
| Background | Ibuprofen | Small molecule | 10 mg/kg | — |
Indications
No indication recorded.