Intranasal Ketorolac Trial

Last updated: July 22, 2024
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

2

Condition

Oral Facial Pain

Pain (Pediatric)

Migraine (Adult)

Treatment

Ketorolac

Prochlorperazine

Diphenhydramine

Clinical Study ID

NCT06083571
202307050
  • Ages 6-17
  • All Genders
  • Accepts Healthy Volunteers

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A headache that fulfills at least three of the six following criteria: i) moderateto severe episode of impaired daily activities; ii) focal localization of headache (focal meaning unilateral, bifrontal, bitemporal, or biparietal); iii) pulsatiledescription; iv) nausea or vomiting or abdominal pain; v) photophobia or phonophobiaor avoidance of light and noise; and vi) symptoms increasing with activity orresolving by rest

  • Pain 4/10 on the validated Faces Pain Scale

  • Headache duration between 1 and 72 hours

Exclusion

Exclusion Criteria:

  • Any contraindication to receiving ketorolac (e.g. known allergy, known peptic ulcerdisease, gastrointestinal bleeding, hepatic impairment (patients with knownaspartate 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 < 90mL/min/1.73m2)

  • Known bleeding disorders

  • Receipt of an NSAID (e.g. ibuprofen, naproxen, naproxen/sumatriptan) within previoussix hours

  • Receipt of oral prochlorperazine or metoclopramide or diphenhydramine within 12hours prior to presentation

  • Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readilycleared 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 foracute headaches on more than 10 days per month)

  • Patients refusing to take oral adjuncts or unable to tolerate oral medications willbe excluded from the trial.

  • Patients currently on the following medications will also be excluded from the studyas 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 selectiveserotonin 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).

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Ketorolac
Phase: 2
Study Start date:
January 01, 2024
Estimated Completion Date:
January 01, 2026

Connect with a study center

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

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