Phase
Condition
Oral Facial Pain
Pain (Pediatric)
Migraine (Adult)
Treatment
Ketorolac
Prochlorperazine
Diphenhydramine
Clinical Study ID
Ages 6-17 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
Washington University in St. Louis
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.