Intranasal Ketorolac Trial
Headache, Migraine
About this trial
This is an interventional treatment trial for Headache, Migraine
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intranasal Patients
Intravenous 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)
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)