At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial of Intranasal Ketamine Compared to Intranasal Fentanyl for Analgesia in Children With Suspected, Isolated Extremity Fractures in the Pediatric Emergency Department
In Brief
A Phase 2 clinical trial evaluating ketamine, fentanyl, and 1 other intervention for Bone Fracture. Completed, enrolled 87 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
intranasal (IN) sub-dissociative ketamine (1mg/kg)
Intranasal (IN) fentanyl (1.5 micrograms/kg)
10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention