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

Sponsor

Health Sciences North Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05983354

Collaborator

(none)

Enrollment

Arms

5.9

Anticipated Duration (Months)

Study Details

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

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Migraine Headache	Drug: Oral metoclopramide and ibuprofen Drug: Intravenous metoclopramide and ketorolac	N/A

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. We will also assess frequency of adverse effects commonly associated with study medications, including gastrointestinal upset, patient-reported restlessness or dystonic reaction, and fatigue.

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, we plan to enrol 55 patients.

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 Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Recruitment rate [6 months]
Proportion of eligible patients presenting to ED who are successfully recruited
Pain relief [60 minutes]
Change in visual analogue scale from baseline to 60 minutes after medication administration

Secondary Outcome Measures

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