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NCT02521415 · ClinicalTrials.gov registry record · Phase 2
IN Sub-Dissociative Ketamine vs IN Fentanyl
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
NCT02521415 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 87 participants.
The verdict
NCT02521415, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
Study 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.
Interventions
- DRUG fentanyl
- DRUG ketamine
- DRUG ibuprofen or acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02521415
The ClinicalTrials.gov registry entry for NCT02521415 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which fentanyl is the first listed.
NCT02521415 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02521415 about?
NCT02521415 is a clinical study titled "IN Sub-Dissociative Ketamine vs IN Fentanyl". 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 ...
What is the current status of trial NCT02521415?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2015-12. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02521415?
The interventions under investigation include: fentanyl (DRUG), ketamine (DRUG), ibuprofen or acetaminophen (DRUG).
Who is sponsoring clinical trial NCT02521415?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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