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

NCT ID: NCT02358681

Last Updated: 2022-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-16
• Study Completion Date: 2021-03-31

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.

Detailed Description

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 there is a difference in time to achieve a clinically significant reduction in pain after receiving IN ketorolac compared to IV ketorolac. We hypothesize that there is no difference between IN ketorolac and 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 at 10 minutes, 30 minutes and 60 minutes after administration of the study drug. The patient will then be assessed at 2 hours and 24 hours after study drug administration for outcomes related to efficacy, function, and safety.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketorolac, intranasal

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

2. Placebo, intravenous.

Group Type: EXPERIMENTAL

Ketorolac, intranasal

Intervention Type: DRUG

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

Placebo, intravenous

Intervention Type: DRUG

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

Ketorolac, intravenous

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

2. Placebo, intranasal.

Group Type: ACTIVE_COMPARATOR

Ketorolac, intravenous

Intervention Type: DRUG

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

Placebo, intranasal

Intervention Type: DRUG

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

Interventions

Ketorolac, intranasal

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

Intervention Type: DRUG

Ketorolac, intravenous

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

Intervention Type: DRUG

Placebo, intravenous

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

Intervention Type: DRUG

Placebo, intranasal

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

Intervention Type: DRUG

Other Intervention Names

Toradol; Toradol

Eligibility 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).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Migraine Research Foundation

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Daniel S Tsze, MD, MPH

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel S Tsze, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

NewYork Presbyterian Morgan Stanley Children's Hospital

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAO1302

Identifier Type: -

Identifier Source: org_study_id