Status:
RECRUITING
Intranasal Ketorolac Trial
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Assertio Holdings, Inc
Conditions:
Headache, Migraine
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief 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 o...
Eligibility Criteria
Inclusion
- 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
- 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
- Frequent use of drugs for headache (defined as regular intake of analgesics for acute headaches on more than 10 days per month)
- Patients refusing to take oral adjuncts or unable to tolerate oral medications will be excluded from the trial.
- Patients currently on the following medications will also be excluded from the study as there are contraindications for use of Ketorolac with use of these medications: antiplatelets (i.e. salicylates, aspirin, clopidogrel, ticagrelor), Anticoagulants (i.e. warfarin, rivaroxaban, apixaban, dabigatran, enoxaparin, and heparin), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (losartan, Lisinopril), cyclosporine or tacrolimus, furosemide, bumetanide, spironolactone, hydrochlorothiazide, digoxin, lithium, methotrexate, probenecid, some selective serotonin reuptake inhibitors (including i.e. citalopram, escitalopram, sertraline), antipsychotics (i.e. Quetiapine, risperidone, aripiprazole, haloperidol), tranylcypromine, oxybates, oral potassium citrate, and Anticholinergics (i.e. amantadine).
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06083571
Start Date
January 1 2024
End Date
January 1 2026
Last Update
July 24 2024
Active Locations (1)
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1
Washington University in St. Louis
St Louis, Missouri, United States, 63110