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

NCT02358681 | Completed Phase 3 Results DMC

• 1 other identifier: AAAO1302
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Migraine

Keywords

Intranasal; Ketorolac; Pediatric; Migraine; Headache

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score After Analgesic Administration (Faces Pain Scale - Revised (FPS-R)

  Measure the change in pain score after administration of analgesic using the Faces Pain Scale - Revised (FPS-R) at 60 minutes after analgesic administration. The FPS-R is scored from 0 (no pain) to 10 (maximum pain intensity, i.e. worst outcome).

  60 minutes

Secondary Outcomes (1)

• Time to Achieve Clinically Significant Reduction in Pain After Analgesic Administration (Pain Score)

  10, 30, 60 and 120 minutes

Other Outcomes (9)

• Adverse Events

  24 hours

• Number of Participants Who Received Rescue Medications During Emergency Department Visit

  12 hours

• Number of Participants Who Experienced Headache Relief During Emergency Department Visit

  2 hours

Study Arms (2)

Ketorolac, intranasal

EXPERIMENTAL

1. Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route, single dose. 2. Placebo, intravenous.

Drug: Ketorolac, intranasal; Drug: Placebo, intravenous

Ketorolac, intravenous

ACTIVE COMPARATOR

1. Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route, single dose. 2. Placebo, intranasal.

Drug: Ketorolac, intravenous; Drug: Placebo, intranasal

Interventions

Ketorolac, intranasal DRUG

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

Also known as: Toradol

Ketorolac, intranasal

Ketorolac, intravenous DRUG

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

Also known as: Toradol

Ketorolac, intravenous

Placebo, intravenous DRUG

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

Ketorolac, intranasal

Placebo, intranasal DRUG

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

Ketorolac, intravenous

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Columbia University: lead
• Migraine Research Foundation: collaborator

Study Sites (1)

NewYork Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Daniel Tsze MD MPH
• Organization: Columbia University

dst2141@cumc.columbia.edu

212-317-0997

Study Officials

• Daniel S Tsze, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 9, 2015
• Study Start: June 16, 2015
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: January 12, 2022
• Results First Posted: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)