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

Primary Purpose

Acute Migraine Headache

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral metoclopramide and ibuprofen
Intravenous metoclopramide and ketorolac
Sponsored by
Health Sciences North Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Migraine Headache focused on measuring emergency department, migraine, metoclopramide

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - Presentation to emergency department with headache Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Oral medications

    IV medications

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Recruitment rate
    Proportion of eligible patients presenting to ED who are successfully recruited
    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

    Secondary Outcome Measures

    Proportion of eligible patients approached
    Proportion of all eligible patients who were approached by research assistants
    Rate of attrition during the study period
    Number of patients recruited to study who ended participation during study period
    Pain relief at 2 hours
    Change in visual analogue scale from baseline to 120 minutes after medication administration
    Freedom from headache
    Patients who report complete resolution of headache at 60 minutes from medication administration
    Need for rescue medication
    Additional medications administered by treating physician after 60 minutes
    Emergency department length of stay
    Time from initial physician assessment to discharge
    Return to emergency department
    Patients who were registered again to the ED within 24 hours of discharge
    Adverse reactions
    Any adverse reaction reported during the study period

    Full Information

    First Posted
    August 1, 2023
    Last Updated
    September 22, 2023
    Sponsor
    Health Sciences North Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05983354
    Brief Title
    Oral Medications for the Management of Acute Migraine Headache in the Emergency Department
    Official Title
    Oral v. Parenteral Medications for the Emergency Management of Acute Migraine: a Pilot Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Health Sciences North Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Objectives The planned study is a pilot study designed to assess the feasibility of our recruitment and data collection strategy. The primary feasibility outcome will be recruitment rate, which is defined as the proportion of eligible patients approached who are successfully recruited over the proposed 6-month pilot study period. Our secondary feasibility outcomes are (a) proportion of eligible patients approached and (b) rate of attrition during the study period. Our preliminary primary outcome will be improvement in pain from baseline to 60 minutes after medication administration using the visual analogue scale (Bijur et al. 2008). Preliminary secondary outcomes will include headache relief and freedom from headache at 2 h, the need for rescue medication, ED length of stay and return to ED within 24h of discharge. The frequency of adverse effects, including gastrointestinal upset, patient-reported restlessness or dystonic reaction and fatigue, will be assessed. Design In this parallel, noninferiority, double-blind randomised control pilot study, eligible patients presenting to the emergency department with a chief complaint of headache will be randomly assigned with an allocation ratio of 1:1 to receive one of 2 treatments: intravenous ketorolac (10 mg) and metoclopramide (10 mg) v. oral ibuprofen (400 mg) and metoclopramide (10 mg). Dosing was selected to reflect the lowest effective doses recommended for emergency department management of migraine headaches (Friedman et al. 2011, Motov et al. 2017). The study will last 6 months at which time it will stop. Study population Patients between the ages of 18 and 64 presenting to the ED with a chief complaint of headache will be eligible to participate in the study. Exclusion criteria include vomiting or inability to tolerate oral medications at the time of medication administration, focal neurologic symptoms, head trauma within 14 days, history of renal disease, contraindication to NSAIDs including pregnancy or concurrent use of blood thinners, hypersensitivity reaction to any of the study medications, or >15 headache days per month. Study procedures Treatment will be assigned using a random number generator. Contents of treatment, which will be identical in appearance, will be known only to the research pharmacist and this information will be stored remotely from the ED. Administering nurses and treating physicians will be blind to the treatment group, as will patients and research assistants collecting outcome data. Data collection Data will be collected using patient interviews immediately prior to medication administration and repeated at 1 and 2 hours after medication administration. A chart review will then be conducted to check for return visits within 24 h of ED discharge. Enrolment: Based on sample size calculations, 55 patients will be enrolled. Statistical procedures: Primary and secondary feasibility outcomes will be reported as the proportion of patients approached who were recruited, proportion of eligible patients approached and the proportion who withdrew consent during the study period +/- 95% CI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Migraine Headache
    Keywords
    emergency department, migraine, metoclopramide

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    55 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral medications
    Arm Type
    Experimental
    Arm Description
    10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml NS administered over 15 minutes.
    Arm Title
    IV medications
    Arm Type
    Active Comparator
    Arm Description
    2 x placebo tablets, 10 mg metoclopramide in 50 cc NS and 10 mg ketorolac in 50 ml NS administered over 15 min.
    Intervention Type
    Drug
    Intervention Name(s)
    Oral metoclopramide and ibuprofen
    Other Intervention Name(s)
    Maxeran, Reglan
    Intervention Description
    10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml normal saline IV administered over 15 minutes.
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous metoclopramide and ketorolac
    Other Intervention Name(s)
    Maxeran, Reglan, Toradol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Recruitment rate
    Description
    Proportion of eligible patients presenting to ED who are successfully recruited
    Time Frame
    6 months
    Title
    Pain relief
    Description
    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
    Time Frame
    60 minutes
    Secondary Outcome Measure Information:
    Title
    Proportion of eligible patients approached
    Description
    Proportion of all eligible patients who were approached by research assistants
    Time Frame
    6 months
    Title
    Rate of attrition during the study period
    Description
    Number of patients recruited to study who ended participation during study period
    Time Frame
    24 hours
    Title
    Pain relief at 2 hours
    Description
    Change in visual analogue scale from baseline to 120 minutes after medication administration
    Time Frame
    120 minutes
    Title
    Freedom from headache
    Description
    Patients who report complete resolution of headache at 60 minutes from medication administration
    Time Frame
    60 minutes
    Title
    Need for rescue medication
    Description
    Additional medications administered by treating physician after 60 minutes
    Time Frame
    24 h
    Title
    Emergency department length of stay
    Description
    Time from initial physician assessment to discharge
    Time Frame
    24 hours
    Title
    Return to emergency department
    Description
    Patients who were registered again to the ED within 24 hours of discharge
    Time Frame
    24 hours
    Title
    Adverse reactions
    Description
    Any adverse reaction reported during the study period
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Presentation to emergency department with headache Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Ohle, MBBCh
    Phone
    (705) 523-7100
    Ext
    7095
    Email
    robert.ohle@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caitlin Dmitriew, MD
    Email
    cdmitriew@nosm.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert Ohle, MBBCh
    Organizational Affiliation
    Health Sciences North Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18285561
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    11733293
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    25600719
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33349955
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21227540
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27993418
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30106228
    Citation
    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.
    Results Reference
    background

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

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