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TerminatedPhase 2

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