Oral Medications for the Management of Acute Migraine Headache in the Emergency Department

NCT05983354 | Unknown

• 1 other identifier: 23-016
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this pilot randomized control trial is to assess the feasibility of our patient recruitment and data collection strategy ahead of a full scale RCT investigating the efficacy of oral v. parenteral medications in the management of acute migraine headaches in the emergency department. Patients will be randomly assigned to receive either (A) standard medical therapy for the treatment of acute migraine headache (metoclopramide and ketorolac IV) and oral placebo or (B) oral metoclopramide and ibuprofen with normal saline IV. Primary outcome measures are recruitment rate and improvement in pain score at 60 minutes from medication administration.

Conditions

Acute Migraine Headache

Keywords

emergency department; migraine; metoclopramide

Outcome Measures

Primary Outcomes (2)

• Recruitment rate

  Proportion of eligible patients presenting to ED who are successfully recruited

  6 months

• Pain relief

  Change in visual analogue scale (0-10 where 0 is no pain and 10 is maximal pain) from baseline to 60 minutes after medication administration

  60 minutes

Secondary Outcomes (8)

• Proportion of eligible patients approached

  6 months

• Rate of attrition during the study period

  24 hours

• Pain relief at 2 hours

  120 minutes

• Freedom from headache

  60 minutes

• Need for rescue medication

  24 h

Study Arms (2)

Oral medications

EXPERIMENTAL

10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml NS administered over 15 minutes.

Drug: Oral metoclopramide and ibuprofen

IV medications

ACTIVE COMPARATOR

2 x placebo tablets, 10 mg metoclopramide in 50 cc NS and 10 mg ketorolac in 50 ml NS administered over 15 min.

Drug: Intravenous metoclopramide and ketorolac

Interventions

Oral metoclopramide and ibuprofen DRUG

10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml normal saline IV administered over 15 minutes.

Also known as: Maxeran, Reglan

Oral medications

Intravenous metoclopramide and ketorolac DRUG

10 mg of metoclopramide IV in 50 ml normal saline, 10 mg ketorolac IV in 50 ml normal saline administered over 15 minutes, with 2 placebo tablets.

Also known as: Maxeran, Reglan, Toradol

IV medications

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Presentation to emergency department with headache

You may not qualify if:

• Vomiting or unable to tolerate PO at tie of med admin
• Focal neurologic symptoms
• Head trauma within 14d
• Pregnancy
• Concurrent use of blood thinners
• Hypersensitivity reaction to any of the study medications
• \>14 HA days per month

Sponsors & Collaborators

• Health Sciences North Research Institute: lead

Related Publications (7)

• Azzopardi TD, Brooks NA. Oral metoclopramide as an adjunct to analgesics for the outpatient treatment of acute migraine. Ann Pharmacother. 2008 Mar;42(3):397-402. doi: 10.1345/aph.1K481. Epub 2008 Feb 19.

  PMID: 18285561 BACKGROUND

• Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

  PMID: 11733293 BACKGROUND

• Burch RC, Loder S, Loder E, Smitherman TA. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015 Jan;55(1):21-34. doi: 10.1111/head.12482. Erratum In: Headache. 2015 Feb;55(2):356.

  PMID: 25600719 BACKGROUND

• Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: Updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache. 2021 Jan;61(1):60-68. doi: 10.1111/head.14024. Epub 2020 Dec 21.

  PMID: 33349955 BACKGROUND

• Friedman BW, Mulvey L, Esses D, Solorzano C, Paternoster J, Lipton RB, Gallagher EJ. Metoclopramide for acute migraine: a dose-finding randomized clinical trial. Ann Emerg Med. 2011 May;57(5):475-82.e1. doi: 10.1016/j.annemergmed.2010.11.023. Epub 2011 Jan 12.

  PMID: 21227540 BACKGROUND

• Motov S, Yasavolian M, Likourezos A, Pushkar I, Hossain R, Drapkin J, Cohen V, Filk N, Smith A, Huang F, Rockoff B, Homel P, Fromm C. Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2017 Aug;70(2):177-184. doi: 10.1016/j.annemergmed.2016.10.014. Epub 2016 Dec 16.

  PMID: 27993418 BACKGROUND

• Yeh WZ, Blizzard L, Taylor BV. What is the actual prevalence of migraine? Brain Behav. 2018 Jun;8(6):e00950. doi: 10.1002/brb3.950. Epub 2018 May 2.

  PMID: 30106228 BACKGROUND

MeSH Terms

Conditions

Emergencies; Migraine Disorders

Interventions

Metoclopramide; Ibuprofen; Ketorolac; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Phenylpropionates; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robert Ohle, MBBCh

  Health Sciences North Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Ohle, MBBCh

CONTACT

(705) 523-7100; robert.ohle@gmail.com

Caitlin Dmitriew, MD

CONTACT

cdmitriew@nosm.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment will be randomly assigned using a random number generator by an independent research assistant who is not involved in data collection. Contents of treatment will be known only to the research pharmacist and this information will be stored remotely from the ED; patients, administering nurses and treating physicians will be blind to the treatment group, as well the research assistants collecting outcome data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share