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NCT06083571 · ClinicalTrials.gov registry record · Phase 2
Intranasal Ketorolac Trial
A Phase 2 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT06083571: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.
NCT06083571 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06083571, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if intranasal (IN) Ketorolac in combination with oral Prochlorperazine and Diphenhydramine is non-inferior to current migraine management which involves use of intravenous (IV) Ketorolac and oral adjuncts Prochlorperazine and diphenhydramine for reducing pain intensity in children with migraine headaches. The investigators hypothesize that IN ketorolac combined with these oral adjuncts is non-inferior to IV ketorolac and oral adjuncts in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration.
Primary Outcome
The Faces Pain Scale - Revised. This is a 10-point pain scale (0-10) that has been validated for the use in children greater than 4 years of age in the ED; is one of the self-report measures of pain recommended for research in children; and is commonly used as the primary outcome in Emergency Department research. Lower numbers are better outcomes.
Interventions
- DRUG Ketorolac
- DRUG Diphenhydramine
- DRUG Prochlorperazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
Why NCT06083571 stopped before completion
NCT06083571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 3 interventions - of which Ketorolac is the first listed.
NCT06083571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06083571 about?
NCT06083571 is a clinical study titled "Intranasal Ketorolac Trial". The purpose of this study is to determine if intranasal (IN) Ketorolac in combination with oral Prochlorperazine and Diphenhydramine is non-inferior to current migraine management which involves use of intravenous (IV) Ketorolac and oral adjuncts Prochlorperazine and diphenhydramine for reducing pai...
What is the current status of trial NCT06083571?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2024-01-01. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT06083571?
The interventions under investigation include: Ketorolac (DRUG), Diphenhydramine (DRUG), Prochlorperazine (DRUG).
Who is sponsoring clinical trial NCT06083571?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06083571's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 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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