HeadacheNCT02697071
Ketamine for Acute Migraine in the Emergency Department
A study testing Ketamine and Normal Saline in people with Headache, run by Carilion Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache
- What is being tested?
- Ketamine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Roanoke Memorial Emergency Department
Roanoke, Virginia, 24014
About this study
Official title: 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.
Read the 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:
- The proportion of patients achieving significant pain reduction at 30 minutes will be higher in the ketamine treatment group compared to the placebo group.
- 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.
- Patients treated with ketamine for headache will experience lower recurrence rates within 24 hours
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
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.
Normal SalineDrug
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 group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Patients will receive an equivalent volume of normal saline intravenously. Receives: Drug: Normal Saline |
| Ketamine | Experimental | Patients will receive 0.2mg/kg ketamine intravenously over one minute. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of Pain Response After Ketamine Dose.
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.
Measured: 30 minutes
Secondary outcomes (1)
Categorical Pain Score Change From Baseline
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")
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Corey Heitz, Carilion Clinic
- Investigators
- Corey Corey, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697071
- Sponsor's protocol ID
- 1921
- Status last verified
- Mar 2021
- First submitted
- 24 Feb 2016
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Trial of Sub-Dissociative Ketamine for Treatment of Acute Migraine-Type Headache in the Emergency Department
- ClinicalTrials.gov ID
- NCT02697071
- Acronym / sponsor ID
- 1921
- Conditions
- Headache
- Keywords
- Ketamine, Migraine, Headache, Emergency Department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- Feb 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 3 Mar 2016 (estimated)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The proportion of patients achieving significant pain reduction at 30 minutes will be higher in the ketamine treatment group compared to the placebo group.
- 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.
- Patients treated with ketamine for headache will experience lower recurrence rates within 24 hours
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Drug: Normal SalinePatients will receive an equivalent volume of normal saline intravenously. |
| Ketamine | Experimental | Drug: KetaminePatients will receive 0.2mg/kg ketamine intravenously over one minute. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetaminePatients 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 | Ketamine |
| Normal SalinePatients 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. | Drug | Placebo Control |
Primary outcome
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.
1 secondary outcome
Categorical Pain Score Change From Baseline
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey Corey, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine and Normal Saline in people with Headache, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of Pain Response After Ketamine Dose. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.