Intranasal Ketorolac for treating migraine in children

Efficacy of Nasal Migraine Cocktail Used In Pediatric Emergency Department: A Clinical Trial

This study tests if a nasal spray of Ketorolac, used with other medications, can help children with moderate to severe migraines feel better just as well as the standard IV treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 6 Years to 17 Years
• Sex: All
• Sponsor: Washington University School of Medicine (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Saint Louis, Missouri)
• Trial ID: NCT06083571 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of intranasal Ketorolac combined with oral Prochlorperazine and Diphenhydramine in comparison to the standard intravenous Ketorolac treatment for migraine headaches in children. The goal is to determine if the intranasal approach is non-inferior in reducing pain intensity within 60 minutes of administration. The study focuses on children experiencing moderate to severe migraine episodes and aims to provide a less invasive treatment option. Participants will be monitored for pain relief and any adverse effects.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 17 years who experience moderate to severe migraine headaches meeting specific criteria.

Not a fit: Patients with contraindications to ketorolac or those with renal impairment or bleeding disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more accessible and less invasive option for managing acute migraine pain in children.

How similar studies have performed: Previous studies have shown promising results with intranasal medications for pain management, suggesting potential success for this approach.

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).

Where this trial is running

Saint Louis, Missouri

• Washington University in St. Louis — Saint Louis, Missouri, United States (Recruiting)

Study contacts

• Principal investigator: Carlee Lenehan, MD — Washington University in St. Louis: st. louis childrens hospital
• Study coordinator: Carlee Lenehan, MD

Conditions Headache, Migraine