Intranasal Ketorolac Trial
Key facts
- Who runs it
- Washington University School of Medicine
- Where
- St Louis, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 41 people enrolled
- Started
- 1 Jan 2024
- Ended
- 31 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ketorolac
- Prochlorperazine
- Diphenhydramine
- Record updated
- 16 January 2026
- Why it stopped
- The eligibility criteria within the protocol led to the exclusion of a large proportion of potential participants, thereby limiting enrollment. During the conceptualization phase, the number of eligible patients was overestimated.
Who can take part
- Age
- 6 years to 17 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Patients with a concurrent diagnosis of traumatic brain injury
- 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
- Renal impairment (patients with known estimated glomerular filtration rate of < 90 mL/min/1.73m2)
- Known bleeding disorders
- Unable to complete self-report measures of pain or questionnaires (e.g. developmental delay, neurologic impairment)
- Critical illness
- 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)
- 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)
- Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared using suction or nose blowing
- Inability to speak English
Where in United States
- Washington University in St. LouisSt Louis, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Intranasal PatientsTreatment being tested
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)
Treatment: Ketorolac, Prochlorperazine, and Diphenhydramine
- Intravenous PatientsExisting treatment, for comparison
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: Ketorolac, Prochlorperazine, and Diphenhydramine
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Nasal Migraine Cocktail Used In Pediatric Emergency Department: A Clinical Trial
- Record updated
- 16 January 2026