At a glance
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Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children: A Randomized Non-inferiority Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Ketorolac, intranasal, Ketorolac, intravenous, and 2 other interventions for Migraine. Completed, enrolled 59 participants across 1 site.
Detailed Summary
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 Details
Timeline
Interventions
Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.
Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.
Placebo of equal volume to IV ketorolac, to be administered by intravenous route.
Placebo of equal volume to IN ketorolac, to be administered by intranasal route.