Overview

Intranasal Ketorolac Trial

Status:
Not yet recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Washington University School of Medicine
Collaborator:
Assertio Holdings, Inc
Treatments:
Diphenhydramine
Ketorolac
Prochlorperazine
Promethazine