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Intranasal Ketorolac Trial | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Intranasal Ketorolac Trial

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

NCT06083571•Washington University School of Medicine

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.

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•A headache that fulfills at least three of the six following criteria: i) moderate to severe episode of impaired daily activities; ii) focal localization of headache (focal meaning unilateral, bifrontal, bitemporal, or biparietal); iii) pulsatile description; iv) nausea or vomiting or abdominal pain; v) photophobia or phonophobia or avoidance of light and noise; and vi) symptoms increasing with activity or resolving by rest
•Pain 4/10 on the validated Faces Pain Scale
•Headache duration between 1 and 72 hours

Exclusion Criteria

•Any contraindication to receiving ketorolac (e.g. known allergy, known peptic ulcer disease, gastrointestinal bleeding, hepatic impairment (patients with known aspartate aminotransferase (AST) \> 60 units/L "OR" alanine aminotransferase (ALT) \> 40 units/L "OR" total bilirubin \> 1.2 mg/dl)
•Renal impairment (patients with known estimated glomerular filtration rate of \< 90 mL/min/1.73m2)
•Known bleeding disorders
•Receipt of an NSAID (e.g. ibuprofen, naproxen, naproxen/sumatriptan) within previous six hours
•Receipt of oral prochlorperazine or metoclopramide or diphenhydramine within 12 hours prior to presentation
•Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared using suction or nose blowing
•Inability to speak English
•Patients with a concurrent diagnosis of traumatic brain injury
•Unable to complete self-report measures of pain or questionnaires (e.g. developmental delay, neurologic impairment)
•Critical illness
+3 more criteria

Locations (1)

Washington University in St. Louis

St Louis, Missouri, United States

Key Dates

Start Date

January 1, 2024

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

January 16, 2026

Enrollment

ACTUAL participants

Conditions

Headache, Migraine

Interventions

Ketorolac

DRUG

Prochlorperazine

DRUG

Diphenhydramine

DRUG

Mind Body Balance for Pediatric Migraine

NCT04715685

HeadacheHeadache Disorders+6 more

View study

RECRUITINGNA

Trial Designs for Evaluating Migraine Treatment

NCT06617832

Migraine with AuraMigraine Without Aura+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Intranasal Ketorolac Trial

Inclusion Criteria

Exclusion Criteria

Mind Body Balance for Pediatric Migraine

Trial Designs for Evaluating Migraine Treatment

Monoclonal Antibody Duration of REsponse in MIgraine After Treatment Interruption

Adolescent Lifestyle Medicine Headache Study

Mind and Body Approaches to Pain Reduction in Youth With Migraine

Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the Headache Impact Questionnaire