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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: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT02521415 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 87 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We will conclude that such a study is NOT feasible if we observe a rate of side effects for ketamine that exceeds fentanyl by three-fold or event rate of 5% or more for ketamine-related significant adverse events. Side effects are common events experienced by patients receiving ketamine or fentanyl that do not change outcomes for the patient but may affect the patient experience. A significant adverse event (SAE) includes any adverse event that begins after the short form consent has been comple
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 |
What the finished NCT02521415 record still lists
NCT02521415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 3 interventions - of which fentanyl is the first listed.
NCT02521415 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02521415's enrollment target sits among peer trials
87 810th of 2000 higher than 1,189 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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