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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Headache
Interventions Drug: Ketamine
Drug: Normal Saline
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Control Ketamine
Hide Arm/Group Description

Patients will receive an equivalent volume of normal saline intravenously.

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.

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

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.

Period Title: Overall Study
Started 18 16
Completed 18 16
Not Completed 0 0
Arm/Group Title Placebo Control Ketamine Total
Hide Arm/Group Description

Patients will receive an equivalent volume of normal saline intravenously.

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.

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

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.

Total of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
30.5  (8.3) 38.5  (13.75) 34.3  (11.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
13
  72.2%
13
  81.3%
26
  76.5%
Male
5
  27.8%
3
  18.8%
8
  23.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  11.1%
3
  18.8%
5
  14.7%
White
13
  72.2%
10
  62.5%
23
  67.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  16.7%
3
  18.8%
6
  17.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 34 participants
18 16 34
Headache duration  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Days (>24h)
6
  33.3%
5
  31.3%
11
  32.4%
Hours (<24h)
11
  61.1%
10
  62.5%
21
  61.8%
Weeks (>7d)
1
   5.6%
1
   6.3%
2
   5.9%
Self-medicated before ED presentation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
15
  83.3%
13
  81.3%
28
  82.4%
Visual Aura Present  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
6
  33.3%
5
  31.3%
11
  32.4%
International Classification of Headache Disorders   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
1.1 - Migraine without aura
9
  50.0%
8
  50.0%
17
  50.0%
1.2 - Migraine with aura
3
  16.7%
5
  31.3%
8
  23.5%
1.5.1 - Probably migraine without aura
3
  16.7%
2
  12.5%
5
  14.7%
1.5.2 - probably migraine with aura
3
  16.7%
1
   6.3%
4
  11.8%
[1]
Measure Description: Participants were categorized using the International Classification of Headache Disorders (ICD-3) into groups based on migraine without (1.1) or with aura (1.2), or probably migraine without (1.5.1) or with (1.5.2) aura. https://ichd-3.org/1-migraine/
Baseline categorical pain intensity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Severe
12
  66.7%
14
  87.5%
26
  76.5%
Severe-moderate
1
   5.6%
0
   0.0%
1
   2.9%
Moderate
4
  22.2%
2
  12.5%
6
  17.6%
Mild
1
   5.6%
0
   0.0%
1
   2.9%
Baseline functional disability  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
No disruption
0
   0.0%
0
   0.0%
0
   0.0%
Mildly impaired
5
  27.8%
4
  25.0%
9
  26.5%
Moderately impaired
6
  33.3%
6
  37.5%
12
  35.3%
Severely impaired
7
  38.9%
6
  37.5%
13
  38.2%
Baseline NRS   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Scores on a scale
Number Analyzed 18 participants 16 participants 34 participants
8
(7 to 9)
8.25
(7.75 to 10)
8
(7 to 9.75)
[1]
Measure Description: NRS = numerical rating scale for pain, from 0-10, where 0 is no pain, and 10 is the most pain they have felt/can imagine feeling. 1-3 are "mild", 4-6 are "moderate", and 7-10 are considered "severe" pain.
1.Primary Outcome
Title Achievement of Pain Response After Ketamine Dose.
Hide Description 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.
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Control Ketamine
Hide Arm/Group Description:

Patients will receive an equivalent volume of normal saline intravenously.

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.

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

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.

Overall Number of Participants Analyzed 18 16
Median (Inter-Quartile Range)
Unit of Measure: change in score on a scale
2.0
(0 to 3.75)
1.0
(0 to 2.25)
2.Secondary Outcome
Title Categorical Pain Score Change From Baseline
Hide Description 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")
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Control Ketamine
Hide Arm/Group Description:

Patients will receive an equivalent volume of normal saline intravenously.

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.

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

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.

Overall Number of Participants Analyzed 18 16
Mean (95% Confidence Interval)
Unit of Measure: change in score on a scale
0.72
(0.61 to 0.83)
0.56
(0.44 to 0.68)
3.Other Pre-specified Outcome
Title Functional Disability Score Change From Baseline
Hide Description 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")
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Control Ketamine
Hide Arm/Group Description:

Patients will receive an equivalent volume of normal saline intravenously.

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.

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

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.

Overall Number of Participants Analyzed 18 16
Mean (95% Confidence Interval)
Unit of Measure: change in score on a scale
0.39
(0.3 to 0.48)
0.44
(0.32 to 0.56)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Control Ketamine
Hide Arm/Group Description

Patients will receive an equivalent volume of normal saline intravenously.

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.

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

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.

All-Cause Mortality
Placebo Control Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
Placebo Control Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Control Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 

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.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Corey Heitz, MD
Organization: Lewis Gale Medical Center
Phone: 5406322364
EMail: coreyheitzmd@gmail.com
Layout table for additonal information
Responsible Party: Corey Heitz, Carilion Clinic
ClinicalTrials.gov Identifier: NCT02697071    
Other Study ID Numbers: 1921
First Submitted: February 24, 2016
First Posted: March 3, 2016
Results First Submitted: November 5, 2020
Results First Posted: February 25, 2021
Last Update Posted: March 26, 2021