Overview

Intranasal Ketorolac Versus Intravenous Ketorolac for Treatment of Migraine Headaches in Children

Status:
Completed

Trial end date:
2021-03-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Columbia University

Collaborator:

Migraine Research Foundation

Treatments:

Ketorolac
Ketorolac Tromethamine

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 1-168 hours (7 days) 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 fluids and any IV medication (for example: ketorolac, metoclopramide,
prochlorperazine, ondansetron) 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).