Ketamine for Acute Migraine in the Emergency Department
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches, Hospital |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/1/2017 |
| Start Date: | February 2016 |
| End Date: | December 2018 |
| Contact: | Corey Heitz, MD |
| Email: | crheitz@carilionclinic.org |
| Phone: | 540-981-7000 |
A Randomized Placebo-Controlled Trial of Sub-Dissociative Ketamine for Treatment of Acute Migraine-Type Headache in the Emergency Department
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.
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.
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.
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.
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
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