drugset / Trial / NCT02521415
IN Sub-Dissociative Ketamine vs IN Fentanyl
Phase 2
Completed
87 enrolled
Wake Forest University Health Sciences
Carolinas Trauma Network Research Group · collabCharlotte, Houston, Milwaukee Prehospital Emergency Research Nodal Center-CHaMP-ERNC · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This single center, randomized control, double blind trial will prospectively examine the feasibility of intranasal, sub-dissociative (IN) ketamine versus intranasal fentanyl for pain control in the pediatric emergency department setting. The investigators hypothesize that IN ketamine may provide a safe and effective alternative to IN fentanyl for children with suspected, isolated extremity fractures. Eighty children ages 3-17 years with a suspected, isolated extremity fracture that requires analgesia will be randomized to receive IN ketamine or IN fentanyl upon presentation to the emergency department and will be followed for 2 hours for efficacy and 6 hours for safety.
Timeline
- Start
- 2015-12
- Primary completion
- 2016-11
- Completion
- 2016-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 1.5 ug/kg | Intranasal |
| Subject | Ketamine | Small molecule | 1 mg/kg | Intranasal |
| Background | Acetaminophen | Small molecule | 15 mg/kg | — |
| Background | Ibuprofen | Small molecule | 10 mg/kg | — |