Ketamine for Acute Migraine in the Emergency Department

NCT02697071 | Completed Results

• 1 other identifier: 1921
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will be a prospective, randomized, double-blind, placebo-controlled trial. Because ketamine has yet to be directly studied as treatment for acute migraine headache in the emergency department, the research team is initially interested if ketamine can reduce pain scores in headache patients and reduce the incidence of recurrence while exhibiting an adequate safety profile. By using a placebo-controlled study design, the research team can adequately investigate the effectiveness of the medication in a subgroup previously not well studied.

Conditions

Headache

Keywords

Ketamine; Migraine; Headache; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Achievement of Pain Response After Ketamine Dose.

  NRS (National rating scale) pain score change from baseline following ketamine dose. Minimum score is 0, maximum score is 10, and higher scores mean worse pain.

  30 minutes

Secondary Outcomes (1)

• Categorical Pain Score Change From Baseline

  30 minutes

Other Outcomes (1)

• Functional Disability Score Change From Baseline

  30 minutes

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Patients will receive an equivalent volume of normal saline intravenously.

Drug: Normal Saline

Ketamine

EXPERIMENTAL

Patients will receive 0.2mg/kg ketamine intravenously over one minute.

Drug: Ketamine

Interventions

Ketamine DRUG

Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.

Ketamine

Normal Saline DRUG

Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.

Placebo Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Chief complaint of headache
• International Classification of Headache Disorder classification of migraine or probable migraine with or without aura
• Has decision making capacity
• Consent
• Provider determination of non-emergent cause

You may not qualify if:

• Over the age of 50 with first time headache
• Known adverse reaction or tolerance to study medication
• Headache due to trauma
• New onset, focal, abnormal, neurologic findings
• New onset seizures
• History of metastatic cancer or neoplasm
• Active psychotic symptoms
• Altered mental status
• Provider intends to preform lumbar puncture
• Pregnancy
• Breast feeding
• Previous enrollment in study
• Fever \> 100.3 F
• Physiologic instability (blood pressure \< 90/50 or \>170/100, heart rate \<50 or \>120, chronic respiratory, renal or hepatic failure)
• Suspected cardiac pain

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Roanoke Memorial Emergency Department

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Headache; Migraine Disorders; Emergencies

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

A limitation in our study was the chosen ketamine dose. The subjective quality of patient-reported data in pain studies is a limitation. Another limitation in our study was maintaining strict control over additional medications given before or within 30 minutes of study drug administration. Another limitation was quantification of worsening migraine side effects. The final limitations include study location and sample size - single institution in a small city surrounded by a rural area.

Results Point of Contact

• Title: Corey Heitz, MD
• Organization: Lewis Gale Medical Center

coreyheitzmd@gmail.com

5406322364

Study Officials

• Corey Corey, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Undergraduate Medical Education, Department of Emergency Medicine

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 3, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 26, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-03

Locations

US (1)