New York, New York 10032


Purpose:

Ketorolac is an evidence-based, first-line acute migraine therapy that is commonly used in the pediatric population; however, it is typically administered by the intravenous (IV) or intramuscular (IM) routes, both of which require a painful and distressing needle stick to administer. The intranasal (IN) route is a painless and effective way of administering analgesics, including ketorolac: IN ketorolac has been shown to be an effective analgesic in adults for painful conditions, including acute migraine headaches. However, IN ketorolac has been understudied in children, and it is not known how effective it is compared to IV ketorolac, which is currently the most common way of administering ketorolac to children. If IN ketorolac is shown to be no less effective than IV ketorolac, IN ketorolac may be a viable and painless alternative to effectively treat acute migraine headaches in children. Therefore, our primary aim is to demonstrate that IN ketorolac is non-inferior to IV ketorolac for reducing pain in children with acute migraine headaches.


Study summary:

Primary Aim: Determine whether intranasal (IN) ketorolac is non-inferior to intravenous (IV) ketorolac for reducing pain in children with acute migraine headaches. We hypothesize that IN ketorolac is non-inferior to IV ketorolac in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration. Secondary Aim: Determine whether the time to achieve a clinically significant reduction in pain after receiving IN ketorolac is non-inferior to IV ketorolac. We hypothesize that IN ketorolac is non-inferior to IV ketorolac in the time it takes to achieve a clinically significant reduction in pain. We will conduct a prospective, double-blinded, randomized, non-inferiority, parallel 1:1 clinical trial of eligible children in a single urban pediatric ED. We will block randomize patients to receive either 1 mg/kg IN ketorolac and an IV placebo (study group A), or 0.5 mg/kg IV ketorolac and an IN placebo (study group B). We will assess the patient's pain at baseline, and then in 10-minute intervals after administration of the study drug for 60 minutes. The patient will then be assessed at 2 hours and 24 hours after study drug administration for outcomes related to efficacy, function, and safety.


Criteria:

Inclusion Criteria: - Present to the emergency department with a migraine headache as defined by the modified Irma criteria. The modified Irma criteria are as follows: Headache episodes of 1-72 hours presenting with at least 3 of the following 6 criteria: moderate to severe episode of impaired daily activities; focal localization of headache; pulsatile description; nausea or vomiting or abdominal pain; photophobia or phonophobia or avoidance of light and noise; symptoms increasing with activity or resolving by rest. - Headache severity of moderate to severe pain (i.e. at least 4/10 on the Faces Pain Scale - Revised) - Requiring IV ketorolac as part of their headache treatment, as per their treating attending physician Exclusion Criteria: - Contraindication to receiving ketorolac - Receipt of an NSAID within six hours of study drug administration - Presence of an intranasal obstruction that cannot be readily cleared - Inability to speak English or Spanish - Unable to complete self-report measures of pain or questionnaires - Critical illness - Frequent use of drugs for headache (i.e. regular intake of analgesics for acute headaches on more than 10 days per month).


NCT ID:

NCT02358681


Primary Contact:

Principal Investigator
Daniel S Tsze, MD, MPH
Columbia University

Daniel S Tsze, MD, MPH
Phone: 212-305-9825
Email: dst2141@columbia.edu


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States

Daniel S Tsze, MD, MPH
Phone: 212-305-9825
Email: dst2141@columbia.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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