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Ketamine for Acute Migraine in the Emergency Department

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ClinicalTrials.gov Identifier: NCT02697071
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Corey Heitz, Carilion Clinic

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.

Condition or disease Intervention/treatment Phase
Headache Drug: Ketamine Drug: Normal Saline Not Applicable

Detailed Description:

The investigators propose enrollment of patients upon or shortly after presentation to the emergency department for treatment with ketamine or placebo. 30 minutes after study drug is administered, patients will have the option to request rescue medication which will be ordered by the treating physician according to standard emergency department protocol. Pain scores will be documented using the Numerical rating scale (NRS-11), 4-Point Pain Intensity Categorical Scale, and 4-Point Functional Disability Scale at 0 minutes, 30 minutes, and 60 minutes post treatment. Follow-up telephone calls will be made 72-120 hours after treatment to assess the incidence of recurrence of head pain and patient satisfaction with the treatment.

Subjects eligible for this study must present to the emergency department with a chief complaint of primary headache that is determined non-emergent by the treating physician.

Upon block randomization, each subject will receive an intravenous dose of 0.2 mg/kg, with a maximum dose of 30mg, of ketamine or an equivalent volume of saline. After 30 minutes patients will be asked if they need rescue medication, and the treating physician will administer rescue treatment, if requested.

The research hypotheses include:

  1. The proportion of patients achieving significant pain reduction at 30 minutes will be higher in the ketamine treatment group compared to the placebo group.
  2. The proportion of patients experiencing pain response, defined as <50% reduction in the visual analog score compare to the baseline and a reduction of the 4-Point Pain Intensity Categorical Scale to a 1 or 0, will be higher for patients receiving ketamine compared to those receiving the placebo.
  3. Patients treated with ketamine for headache will experience lower recurrence rates within 24 hours
  4. Ketamine will demonstrate an adequate safety profile.

The last two questions will be exploratory and not included in the power analysis.

It is expected that ketamine will demonstrate a satisfactory safety profile with limited side effects. The proportion of patients attaining pain response is expected to be higher in the ketamine treatment group compared to placebo. It is also expected that patients treated with ketamine alone will be less likely to experience a recurring headache within 72 hours of treatment than those treated with placebo and rescue medication.

The primary outcome will be achievement of pain response at 30 minutes after ketamine dose. Achievement of pain response will be defined as reduction in baseline pain score by at least 50% on the NRS scale. Secondary outcomes will include attainment of pain-free state, patient headache relief, recurrence of headache, recovery of functional disability, and need for rescue medication.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Trial of Sub-Dissociative Ketamine for Treatment of Acute Migraine-Type Headache in the Emergency Department
Study Start Date : February 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
Drug Information available for: Ketamine

Arm Intervention/treatment
Placebo Comparator: Placebo Control
Patients will receive an equivalent volume of normal saline intravenously.
Drug: Normal Saline
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.

Experimental: Ketamine
Patients will receive 0.2mg/kg ketamine intravenously over one minute.
Drug: Ketamine
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.




Primary Outcome Measures :
  1. Achievement of pain response after ketamine dose. [ Time Frame: 30 minutes ]
    NRS pain score, categorical pain score and 4-point functional disability score will be recorded before study drug administration and 30 minutes after drug administration.


Secondary Outcome Measures :
  1. Proportion of patients needing rescue treatment [ Time Frame: 30 minutes ]
    The number of patients in each arm that receive rescue medication will be recorded.


Other Outcome Measures:
  1. Percentage of Patients Experiencing Recurring Headache [ Time Frame: 72 hours ]
    Patients will be called 72-120 hours after drug administration and any reported headache recurrences that occurred within 72 hours of treatment will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-65 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697071


Locations
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United States, Virginia
Carilion Roanoke Memorial Emergency Department
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Carilion Clinic
Virginia Polytechnic Institute and State University
Investigators
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Principal Investigator: Corey Corey, MD Carilion Clinic

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Responsible Party: Corey Heitz, Director of Undergraduate Medical Education, Department of Emergency Medicine, Carilion Clinic
ClinicalTrials.gov Identifier: NCT02697071     History of Changes
Other Study ID Numbers: 1921
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by Corey Heitz, Carilion Clinic:
Ketamine
Migraine
Headache
Emergency Department

Additional relevant MeSH terms:
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Migraine Disorders
Emergencies
Headache
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action