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

NCT02358681 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2022-01-12

Study results available
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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.

Conditions

Interventions

DRUG

Ketorolac, intranasal

Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.

DRUG

Ketorolac, intravenous

Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.

DRUG

Placebo, intravenous

Placebo of equal volume to IV ketorolac, to be administered by intravenous route.

DRUG

Placebo, intranasal

Placebo of equal volume to IN ketorolac, to be administered by intranasal route.

Sponsors & Collaborators

Principal Investigators

  • Daniel S Tsze, MD, MPH · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-16
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02358681 on ClinicalTrials.gov