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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes after medication given

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1170