← Back to Search

Nonsteroidal Anti-Inflammatory Drug

Intranasal Ketorolac for Migraines

Phase 2
Recruiting
Led By Carlee Lenehan, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pain 4/10 on the validated Faces Pain Scale
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes after medication given
Awards & highlights

Summary

This trial aims to see if using a combination of intranasal Ketorolac with oral Prochlorperazine and Diphenhydramine is as effective as the current method of treating migraine

Who is the study for?
This trial is for children with migraines that are moderate to severe, affect daily activities, have specific characteristics like pulsating pain or nausea, and last between 1 to 72 hours. Participants must rate their pain at least 4/10 on the Faces Pain Scale.
What is being tested?
The study tests if nasal spray Ketorolac combined with oral Prochlorperazine and Diphenhydramine is as effective as IV Ketorolac for reducing migraine pain in kids within an hour of taking it.
What are the potential side effects?
Ketorolac may cause nose irritation or bleeding, stomach upset, or increase bleeding risk. Prochlorperazine can lead to drowsiness or restlessness. Diphenhydramine often causes sleepiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My pain level is at least 4 out of 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes after medication given
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes after medication given for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in pain on the 10 point Faces Pain Scale-Revised in 2 hours
Secondary study objectives
Response Rate- 2/10 score difference of pain on the Faces Pain Scale- Revised

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intranasal PatientsExperimental Treatment3 Interventions
Intranasal ketorolac (1 spray (15.75mg) if 15kg-29.9kg and 2 sprays (31.5mg) if 30kg or heavier and oral adjuncts oral Prochlorperazine (Between 15-25 kg: dose of 2.5 mg; 26-50 kg: dose of 5 mg; \> 50 kg: dose of 10 mg, single maximum dose 10 mg) and oral Diphenhydramine (Between 15-25 kg: dose of 12.5 mg; 26-50 kg: dose of 25 mg; \> 50 kg: dose of 50 mg, single maximum dose 50mg)
Group II: Intravenous PatientsActive Control3 Interventions
IV ketorolac (0.5 mg/kg, maximum single dose of 30 mg) with oral adjuncts oral Prochlorperazine (Between 15-25 kg: dose of 2.5 mg; 26-50 kg: dose of 5 mg; \> 50 kg: dose of 10 mg, single maximum dose 10 mg) and oral Diphenhydramine (Between 15-25 kg: dose of 12.5 mg; 26-50 kg: dose of 25 mg; \> 50 kg: dose of 50 mg, single maximum dose 50mg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
2014
Completed Phase 4
~1760
Diphenhydramine
2002
Completed Phase 4
~1140
Prochlorperazine
2013
Completed Phase 4
~1990

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,503 Total Patients Enrolled
2 Trials studying Migraine
350 Patients Enrolled for Migraine
Assertio Holdings, IncUNKNOWN
Carlee Lenehan, MDPrincipal InvestigatorWashington University in St. Louis: st. louis childrens hospital
~60 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top