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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
Results First Posted : February 25, 2021
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
Virginia Polytechnic Institute and State University
Information provided by (Responsible Party):
Corey Heitz, Carilion Clinic

Tracking Information
First Submitted Date  ICMJE February 24, 2016
First Posted Date  ICMJE March 3, 2016
Results First Submitted Date  ICMJE November 5, 2020
Results First Posted Date  ICMJE February 25, 2021
Last Update Posted Date March 26, 2021
Study Start Date  ICMJE February 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
Achievement of Pain Response After Ketamine Dose. [ Time Frame: 30 minutes ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2021)
Categorical Pain Score Change From Baseline [ Time Frame: 30 minutes ]
change in baseline categorical pain score at 30 minutes (categorical pain intensity score from 0 to 3 where 0="no headache" and 3="severe headache")
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
Proportion of patients needing rescue treatment [ Time Frame: 30 minutes ]
The number of patients in each arm that receive rescue medication will be recorded.
Current Other Pre-specified Outcome Measures
 (submitted: February 9, 2021)
Functional Disability Score Change From Baseline [ Time Frame: 30 minutes ]
change in functional disability from baseline at 30 minutes (functional disability score from 0 to 3 where 0="no disruption of daily activities" and 3="performance of daily activities is severely impaired")
Original Other Pre-specified Outcome Measures
 (submitted: February 26, 2016)
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.
 
Descriptive Information
Brief Title  ICMJE Ketamine for Acute Migraine in the Emergency Department
Official Title  ICMJE A Randomized Placebo-Controlled Trial of Sub-Dissociative Ketamine for Treatment of Acute Migraine-Type Headache in the Emergency Department
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Headache
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: Placebo Control
    Patients will receive an equivalent volume of normal saline intravenously.
    Intervention: Drug: Normal Saline
  • Experimental: Ketamine
    Patients will receive 0.2mg/kg ketamine intravenously over one minute.
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2021)
34
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2016)
96
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02697071
Other Study ID Numbers  ICMJE 1921
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Corey Heitz, Carilion Clinic
Study Sponsor  ICMJE Carilion Clinic
Collaborators  ICMJE Virginia Polytechnic Institute and State University
Investigators  ICMJE
Principal Investigator: Corey Corey, MD Carilion Clinic
PRS Account Carilion Clinic
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP