NCT06083571

Intranasal Ketorolac Trial

Efficacy of Nasal Migraine Cocktail Used In Pediatric Emergency Department: A Clinical Trial

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Headache, Migraine

Interventions

Type	Name	Description
DRUG	Ketorolac	Non-inferiority
DRUG	Prochlorperazine	Adjunct
DRUG	Diphenhydramine	Adjunct

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-10-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study