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

September 22, 2023 updated by: Health Sciences North Research Institute

Oral v. Parenteral Medications for the Emergency Management of Acute Migraine: a Pilot Randomized Control Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral medications
10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml NS administered over 15 minutes.
Drug: Oral metoclopramide and ibuprofen
10 mg oral metoclopramide, 400 mg oral ibuprofen with 2 x 50 ml normal saline IV administered over 15 minutes.
Other Names:
  • Maxeran, Reglan
Active Comparator: IV medications
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
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.
Other Names:
  • Maxeran, Reglan, Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 6 months
Proportion of eligible patients presenting to ED who are successfully recruited
6 months
Pain relief
Time Frame: 60 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible patients approached
Time Frame: 6 months
Proportion of all eligible patients who were approached by research assistants
6 months
Rate of attrition during the study period
Time Frame: 24 hours
Number of patients recruited to study who ended participation during study period
24 hours
Pain relief at 2 hours
Time Frame: 120 minutes
Change in visual analogue scale from baseline to 120 minutes after medication administration
120 minutes
Freedom from headache
Time Frame: 60 minutes
Patients who report complete resolution of headache at 60 minutes from medication administration
60 minutes
Need for rescue medication
Time Frame: 24 h
Additional medications administered by treating physician after 60 minutes
24 h
Emergency department length of stay
Time Frame: 24 hours
Time from initial physician assessment to discharge
24 hours
Return to emergency department
Time Frame: 24 hours
Patients who were registered again to the ED within 24 hours of discharge
24 hours
Adverse reactions
Time Frame: 24 hours
Any adverse reaction reported during the study period
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Sciences North Research Institute

Investigators

  • Principal Investigator: Robert Ohle, MBBCh, Health Sciences North Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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