TERMINATED

Intranasal Ketorolac Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine if intranasal (IN) Ketorolac in combination with oral Prochlorperazine and Diphenhydramine is non-inferior to current migraine management which involves use of intravenous (IV) Ketorolac and oral adjuncts Prochlorperazine and diphenhydramine for reducing pain intensity in children with migraine headaches. The investigators hypothesize that IN ketorolac combined with these oral adjuncts is non-inferior to IV ketorolac and oral adjuncts in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration.

Official Title

Efficacy of Nasal Migraine Cocktail Used In Pediatric Emergency Department: A Clinical Trial

Quick Facts

Study Start:2024-01-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06083571

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* A headache that fulfills at least three of the six following criteria: i) moderate to severe episode of impaired daily activities; ii) focal localization of headache (focal meaning unilateral, bifrontal, bitemporal, or biparietal); iii) pulsatile description; iv) nausea or vomiting or abdominal pain; v) photophobia or phonophobia or avoidance of light and noise; and vi) symptoms increasing with activity or resolving by rest * Pain 4/10 on the validated Faces Pain Scale * Headache duration between 1 and 72 hours	* Any contraindication to receiving ketorolac (e.g. known allergy, known peptic ulcer disease, gastrointestinal bleeding, hepatic impairment (patients with known aspartate aminotransferase (AST) \> 60 units/L "OR" alanine aminotransferase (ALT) \> 40 units/L "OR" total bilirubin \> 1.2 mg/dl) * Renal impairment (patients with known estimated glomerular filtration rate of \< 90 mL/min/1.73m2) * Known bleeding disorders * Receipt of an NSAID (e.g. ibuprofen, naproxen, naproxen/sumatriptan) within previous six hours * Receipt of oral prochlorperazine or metoclopramide or diphenhydramine within 12 hours prior to presentation * Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared using suction or nose blowing * Inability to speak English * Patients with a concurrent diagnosis of traumatic brain injury * Unable to complete self-report measures of pain or questionnaires (e.g. developmental delay, neurologic impairment) * Critical illness * Frequent use of drugs for headache (defined as regular intake of analgesics for acute headaches on more than 10 days per month) * Patients refusing to take oral adjuncts or unable to tolerate oral medications will be excluded from the trial. * Patients currently on the following medications will also be excluded from the study as there are contraindications for use of Ketorolac with use of these medications: antiplatelets (i.e. salicylates, aspirin, clopidogrel, ticagrelor), Anticoagulants (i.e. warfarin, rivaroxaban, apixaban, dabigatran, enoxaparin, and heparin), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (losartan, Lisinopril), cyclosporine or tacrolimus, furosemide, bumetanide, spironolactone, hydrochlorothiazide, digoxin, lithium, methotrexate, probenecid, some selective serotonin reuptake inhibitors (including i.e. citalopram, escitalopram, sertraline), antipsychotics (i.e. Quetiapine, risperidone, aripiprazole, haloperidol), tranylcypromine, oxybates, oral potassium citrate, and Anticholinergics (i.e. amantadine).

Inclusion Criteria

Exclusion Criteria

* A headache that fulfills at least three of the six following criteria: i) moderate to severe episode of impaired daily activities; ii) focal localization of headache (focal meaning unilateral, bifrontal, bitemporal, or biparietal); iii) pulsatile description; iv) nausea or vomiting or abdominal pain; v) photophobia or phonophobia or avoidance of light and noise; and vi) symptoms increasing with activity or resolving by rest
* Pain 4/10 on the validated Faces Pain Scale
* Headache duration between 1 and 72 hours

* Any contraindication to receiving ketorolac (e.g. known allergy, known peptic ulcer disease, gastrointestinal bleeding, hepatic impairment (patients with known aspartate aminotransferase (AST) \> 60 units/L "OR" alanine aminotransferase (ALT) \> 40 units/L "OR" total bilirubin \> 1.2 mg/dl)
* Renal impairment (patients with known estimated glomerular filtration rate of \< 90 mL/min/1.73m2)
* Known bleeding disorders
* Receipt of an NSAID (e.g. ibuprofen, naproxen, naproxen/sumatriptan) within previous six hours
* Receipt of oral prochlorperazine or metoclopramide or diphenhydramine within 12 hours prior to presentation
* Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared using suction or nose blowing
* Inability to speak English
* Patients with a concurrent diagnosis of traumatic brain injury
* Unable to complete self-report measures of pain or questionnaires (e.g. developmental delay, neurologic impairment)
* Critical illness
* Frequent use of drugs for headache (defined as regular intake of analgesics for acute headaches on more than 10 days per month)
* Patients refusing to take oral adjuncts or unable to tolerate oral medications will be excluded from the trial.
* Patients currently on the following medications will also be excluded from the study as there are contraindications for use of Ketorolac with use of these medications: antiplatelets (i.e. salicylates, aspirin, clopidogrel, ticagrelor), Anticoagulants (i.e. warfarin, rivaroxaban, apixaban, dabigatran, enoxaparin, and heparin), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (losartan, Lisinopril), cyclosporine or tacrolimus, furosemide, bumetanide, spironolactone, hydrochlorothiazide, digoxin, lithium, methotrexate, probenecid, some selective serotonin reuptake inhibitors (including i.e. citalopram, escitalopram, sertraline), antipsychotics (i.e. Quetiapine, risperidone, aripiprazole, haloperidol), tranylcypromine, oxybates, oral potassium citrate, and Anticholinergics (i.e. amantadine).

Contacts and Locations

Principal Investigator

Sophia Rifkin, MD

PRINCIPAL_INVESTIGATOR

Washington University in St. Louis: st. louis childrens hospital

Study Locations (Sites)

Washington University in St. Louis

St Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Sophia Rifkin, MD, PRINCIPAL_INVESTIGATOR, Washington University in St. Louis: st. louis childrens hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-01-01

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Headache, Migraine