Intranasal Ketorolac for Migraines
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before participating. If you are taking NSAIDs (like ibuprofen) within six hours, or oral prochlorperazine, metoclopramide, or diphenhydramine within 12 hours, you cannot participate. Additionally, if you are on specific medications like antiplatelets, anticoagulants, or certain antidepressants, you will be excluded from the study.
What data supports the effectiveness of the drug for treating migraines?
Is intranasal ketorolac safe for humans?
Intranasal ketorolac has been shown to have a safety profile similar to other forms of administration, with no adverse effects on the nasal passages or respiratory system in animal studies. It has also been used safely in humans for pain management, including in patients with migraines and postoperative pain.12467
How is the drug ketorolac unique for treating migraines?
Intranasal ketorolac (SPRIX) is unique for treating migraines because it combines ketorolac, a non-opioid pain reliever, with lidocaine, a numbing agent, and is administered through the nose, offering a non-injection, non-oral option that can be quickly absorbed and effective for acute migraine relief.12489
Research Team
Carlee Lenehan, MD
Principal Investigator
Washington University in St. Louis: st. louis childrens hospital
Eligibility Criteria
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.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intranasal ketorolac with oral adjuncts or intravenous ketorolac with oral adjuncts to manage migraine pain
Follow-up
Participants are monitored for changes in pain intensity using the Faces Pain Scale - Revised at multiple time points after treatment
Treatment Details
Interventions
- Diphenhydramine
- Ketorolac
- Prochlorperazine
Ketorolac is already approved in United States, European Union, Switzerland for the following indications:
- Moderate to severe pain
- Postoperative pain
- Dysmenorrhea
- Idiopathic pericarditis
- Ocular itching
- Moderate to severe pain
- Postoperative pain
- Dysmenorrhea
- Ocular itching
- Inflammation after eye surgery
- Moderate to severe pain
- Moderate to severe pain
- Postoperative pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Assertio Holdings, Inc
Collaborator