Clinical trial NCT02697071: Ketamine for Acute Migraine in the Emergency Department
Official title: A Randomized Placebo-Controlled Trial of Sub-Dissociative Ketamine for Treatment of Acute Migraine-Type Headache in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Keywords: Ketamine
Migraine
Headache
Emergency Department
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2016-03-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Achievement of Pain Response After Ketamine Dose.
timeFrame: 30 minutes
Secondary outcomes:
measure: Categorical Pain Score Change From Baseline
timeFrame: 30 minutes
Other outcomes:
measure: Functional Disability Score Change From Baseline
timeFrame: 30 minutes
Locations:
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Emergency Department
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Corey Corey, MD
role: PRINCIPAL_INVESTIGATOR
References: