Intranasal Ketorolac Trial

NCT ID: NCT06083571

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-31

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 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.

Conditions

Headache, Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intranasal Patients

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)

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

Non-inferiority

Prochlorperazine

Intervention Type: DRUG

Adjunct

Diphenhydramine

Intervention Type: DRUG

Adjunct

Intravenous Patients

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)

Group Type: ACTIVE_COMPARATOR

Ketorolac

Intervention Type: DRUG

Non-inferiority

Prochlorperazine

Intervention Type: DRUG

Adjunct

Diphenhydramine

Intervention Type: DRUG

Adjunct

Interventions

Ketorolac

Non-inferiority

Intervention Type: DRUG

Prochlorperazine

Adjunct

Intervention Type: DRUG

Diphenhydramine

Adjunct

Intervention Type: DRUG

Other Intervention Names

Sprix; Compazine; Benadryl

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assertio Holdings, Inc

UNKNOWN

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophia Rifkin, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University in St. Louis: st. louis childrens hospital

Locations

Washington University in St. Louis

St Louis, Missouri, United States

Countries

United States

References

Kuensting LL, DeBoer S, Holleran R, Shultz BL, Steinmann RA, Venella J. Difficult venous access in children: taking control. J Emerg Nurs. 2009 Sep;35(5):419-24. doi: 10.1016/j.jen.2009.01.014. Epub 2009 Mar 21. No abstract available.

Reference Type: BACKGROUND

PMID: 19748021 (View on PubMed)

Tsze DS, Lubell TR, Carter RC, Chernick LS, DePeter KC, McLaren SH, Kwok MY, Roskind CG, Gonzalez AE, Fan W, Babineau SE, Friedman BW, Dayan PS. Intranasal ketorolac versus intravenous ketorolac for treatment of migraine headaches in children: A randomized clinical trial. Acad Emerg Med. 2022 Apr;29(4):465-475. doi: 10.1111/acem.14422. Epub 2021 Dec 13.

Reference Type: BACKGROUND

PMID: 34822214 (View on PubMed)

Other Identifiers

202307050

Identifier Type: -

Identifier Source: org_study_id