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NCT02358681 · ClinicalTrials.gov registry record · Phase 3
Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children
A Phase 3 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 3
- Development phase
- 59
- Enrollment target
NCT02358681: Completed Phase 3 study, sponsored by Columbia University.
NCT02358681 is a Phase 3 study that has completed, run by Columbia University. The registered enrollment target is 59 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02358681, a Phase 3 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 59 participants
- Enrollment target
Study Summary
Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in the pediatric population; however, it is typically administered by the intravenous (IV) or intramuscular (IM) routes, both of which require a painful and distressing needle stick to administer. The intranasal (IN) route is a painless and effective way of administering analgesics, including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for painful conditions, including acute migraine headaches. However, IN ketorolac has been understudied in children, and it is not known how effective it is compared to IV ketorolac, which is currently the most common way of administering ketorolac to children. If IN ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable and painless alternative to effectively treat acute migraine headaches in children. Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV ketorolac for reducing pain in children with acute migraine headaches.
Primary Outcome
Measure the change in pain score after administration of analgesic using the Faces Pain Scale - Revised (FPS-R) at 60 minutes after analgesic administration. The FPS-R is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome).
Interventions
- DRUG Ketorolac, intranasal
- DRUG Ketorolac, intravenous
- DRUG Placebo, intravenous
- DRUG Placebo, intranasal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2015-06-16 |
| Est. Completion | 2021-03-31 |
| Phase | Phase 3 |
What the finished NCT02358681 record still lists
NCT02358681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Ketorolac, intranasal is the first listed.
NCT02358681 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02358681 about?
NCT02358681 is a clinical study titled "Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children". Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in the pediatric population; however, it is typically administered by the intravenous (IV) or intramuscular (IM) routes, both of which require a painful and distressing needle stick to administer. The intranasal...
What is the current status of trial NCT02358681?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 59 participants. The study started on 2015-06-16. Estimated completion is 2021-03-31.
What interventions are being tested in trial NCT02358681?
The interventions under investigation include: Ketorolac, intranasal (DRUG), Ketorolac, intravenous (DRUG), Placebo, intravenous (DRUG), Placebo, intranasal (DRUG).
Who is sponsoring clinical trial NCT02358681?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02358681's enrollment target sits among peer trials
59 1824th of 2000 higher than 176 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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