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
About this trial
This is an interventional treatment trial for Acute Migraine Headache focused on measuring emergency department, migraine, metoclopramide
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
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
NCT ID
NCT05983354
First Posted
August 1, 2023
Last Updated
September 22, 2023
Sponsor
Health Sciences North Research Institute
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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