HeadachePhase 3CheckNCT02735343
The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine
A Phase 3 study testing Compazine and Ketamine in people with Headache, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial summary
Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in the ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard treatment of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache
- What is being tested?
- Compazine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to May 2017
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years who present to the ED with complaint of a headache
- Temperature less than 100.4 F
- Diastolic blood pressure less than 104 mm Hg
- Normal neurologic exam and normal mental status
Who cannot join
- Pregnant or breastfeeding
- Meningeal signs are present
- Acute angle closure glaucoma is suspected
- Head trauma within the previous two weeks
- Lumbar puncture within the previous two weeks
- Thunderclap (rapid) onset of the headache
Show all 19Show fewer
- Weight more than 150 kg or less than 40 kg
- Known allergy to diphenhydramine
- Known allergy to ondansetron. (Zofran)
- Known allergy to Compazine
- Known allergy to Ketamine
- History of schizophrenia or bipolar disorder
- History of intracranial hypertension
- Is a prisoner
- Patient declined informed consent
- Non-English speaking patient
- Attending provider excludes patient
- Elderly patients with dementia
- Patients with severe headaches that diminish their decision making capability will not be able to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
Official title: The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine. A Multi-Center, Randomized, Double-Blind, Clinical Control Trial
Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in the ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard treatment of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Group 2 (research arm) will receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. Subjects will be seen at 15, 30, 45, and 60 minutes post-intervention to obtain Heart Rate, Blood Pressure, Headache severity, Nausea severity, Vomiting severity, Anxiety severity, and Restlessness severity. At 24-48 hours post intervention we will contact subjects and assess their pain and assess their satisfaction with their migraine pain management as part of this study. Subjects' participation will last up to 48 hours post headache.
Read the detailed description
Screening Visit:
- Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
- Record: Date of birth, age, phone number, gender, race, ethnicity, social security number, name of standard of care rescue medications (over-the-counter and prescription), current email address (to be used for scheduling only), height (in inches), weight (in pounds), history of traumatic brain injury, concussion, or any mild to severe head trauma, medication use. (research only)
- Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) or ESSENTRIS to verify the inclusion/exclusion criteria.
- Women of childbearing potential will have a serum pregnancy test (5-10 milliliters (mls), approximately 1-2 teaspoons of blood) (research-driven).
Visit 1:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS.
- Record type and amount of rescue medications (over-the-counter and prescription) use in the past 7 days. (research only)
- Subjects will be randomized by the pharmacy. We will use a random-number generator and use blocking to ensure roughly equal sample sizes. Both subjects and investigators will be blinded to the study group assignments. Subjects will be randomized by the pharmacy into one of two groups (research-driven):
- Group 1: Standard treatment arm (prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV)
- Group 2: Research arm (Ketamine 0.3 mg/kg along with ondansetron 4 mg IV) 15 minutes post treatment:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS. 30 minutes post treatment:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS. 45 minutes post treatment:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS. 60 minutes post treatment:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS.
24-48 hours post treatment:
- Subjects will be contacted either in-person or via phone and the following information will be collected:
- Subjects will be asked "On a scale of 0-10, with 10 being the worst pain, what is your current level of pain?"
- Subjects will be asked "On a scale of 0 to 10, how satisfied were you with you're the migraine pain management as part of this research study? (dissatisfied 0 - 10 very satisfied)
- Subjects will be alerted to what group they were randomized into.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CompazineDrug
Also called prochlorperazine
Compazine 10mg with diphenhydramine 25 mg IV
KetamineDrug
Ketamine 0.3 mg/kg along with ondansetron 4 mg IV
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment arm | Active comparator | compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously Receives: Drug: Compazine |
| Research arm | Experimental | Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Subjects marked a line on a Visual Analogue Scale rating from None to Severe. Study staff measured the mark in millimeters and converted to a scale from 0 to 100 possible points, with 100 being most severe.
Measured: 15 min, 30 min, 45 min, 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: study goals met
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Christopher Pitotti, MD, Principal investigator, Mike O'Callaghan Federal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735343
- Sponsor's protocol ID
- FWH20160057H
- Acronym
- Check
- Status last verified
- Feb 2024
- First submitted
- 31 Mar 2016
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data will be shared with University Medical Center of Southern Nevada via a Cooperative Research and Development Agreement. They are conducing the same study under a different IRB.
Publications
Driver BE, Klein LR, Carlson K, Harrington J, Reardon RF, Prekker ME. Preoxygenation With Flush Rate Oxygen: Comparing the Nonrebreather Mask With the Bag-Valve Mask. Ann Emerg Med. 2018 Mar;71(3):381-386. doi: 10.1016/j.annemergmed.2017.09.017. Epub 2017 Oct 28.
PubMed 29089172Zitek T, Gates M, Pitotti C, Bartlett A, Patel J, Rahbar A, Forred W, Sontgerath JS, Clark JM. A Comparison of Headache Treatment in the Emergency Department: Prochlorperazine Versus Ketamine. Ann Emerg Med. 2018 Mar;71(3):369-377.e1. doi: 10.1016/j.annemergmed.2017.08.063. Epub 2017 Oct 14.
PubMed 29033296
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine. A Multi-Center, Randomized, Double-Blind, Clinical Control Trial
- ClinicalTrials.gov ID
- NCT02735343
- Acronym / sponsor ID
- Check / FWH20160057H
- Conditions
- Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study goals met
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Aug 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in the ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard treatment of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Group 2 (research arm) will receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. Subjects will be seen at 15, 30, 45, and 60 minutes post-intervention to obtain Heart Rate, Blood Pressure, Headache severity, Nausea severity, Vomiting severity, Anxiety severity, and Restlessness severity. At 24-48 hours post intervention we will contact subjects and assess their pain and assess their satisfaction with their migraine pain management as part of this study. Subjects' participation will last up to 48 hours post headache.
Detailed description
Screening Visit:
- Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
- Record: Date of birth, age, phone number, gender, race, ethnicity, social security number, name of standard of care rescue medications (over-the-counter and prescription), current email address (to be used for scheduling only), height (in inches), weight (in pounds), history of traumatic brain injury, concussion, or any mild to severe head trauma, medication use. (research only)
- Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) or ESSENTRIS to verify the inclusion/exclusion criteria.
- Women of childbearing potential will have a serum pregnancy test (5-10 milliliters (mls), approximately 1-2 teaspoons of blood) (research-driven).
Visit 1:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS.
- Record type and amount of rescue medications (over-the-counter and prescription) use in the past 7 days. (research only)
- Subjects will be randomized by the pharmacy. We will use a random-number generator and use blocking to ensure roughly equal sample sizes. Both subjects and investigators will be blinded to the study group assignments. Subjects will be randomized by the pharmacy into one of two groups (research-driven):
- Group 1: Standard treatment arm (prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV)
- Group 2: Research arm (Ketamine 0.3 mg/kg along with ondansetron 4 mg IV) 15 minutes post treatment:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS. 30 minutes post treatment:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS. 45 minutes post treatment:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS. 60 minutes post treatment:
- Heart rate
- Blood pressure
- Headache severity via 100-mm VAS.
- Nausea severity via 100-mm VAS.
- Vomiting severity via 100-mm VAS.
- Anxiety severity via 100-mm VAS.
- Restlessness severity via 100-mm VAS.
24-48 hours post treatment:
- Subjects will be contacted either in-person or via phone and the following information will be collected:
- Subjects will be asked "On a scale of 0-10, with 10 being the worst pain, what is your current level of pain?"
- Subjects will be asked "On a scale of 0 to 10, how satisfied were you with you're the migraine pain management as part of this research study? (dissatisfied 0 - 10 very satisfied)
- Subjects will be alerted to what group they were randomized into.
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 |
|---|---|---|
| Standard treatment arm | Active comparator | Drug: Compazinecompazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously |
| Research arm | Experimental | Drug: KetamineKetamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 65 years who present to the ED with complaint of a headache
- Temperature less than 100.4 F
- Diastolic blood pressure less than 104 mm Hg
- Normal neurologic exam and normal mental status
Key exclusion criteria (19 listed)
- Pregnant or breastfeeding
- Meningeal signs are present
- Acute angle closure glaucoma is suspected
- Head trauma within the previous two weeks
- Lumbar puncture within the previous two weeks
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 |
|---|---|---|
| CompazineAlso: prochlorperazineCompazine 10mg with diphenhydramine 25 mg IV | Drug | Standard treatment arm |
| KetamineKetamine 0.3 mg/kg along with ondansetron 4 mg IV | Drug | Research arm |
Primary outcome
Pain Score
Time frame: 15 min, 30 min, 45 min, 60 min
Subjects marked a line on a Visual Analogue Scale rating from None to Severe. Study staff measured the mark in millimeters and converted to a scale from 0 to 100 possible points, with 100 being most severe.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29089172Driver BE, Klein LR, Carlson K, Harrington J, Reardon RF, Prekker ME. Preoxygenation With Flush Rate Oxygen: Comparing the Nonrebreather Mask With the Bag-Valve Mask. Ann Emerg Med. 2018 Mar;71(3):381-386. doi: 10.1016/j.annemergmed.2017.09.017. Epub 2017 Oct 28.
- Derived from this study: PubMed 29033296Zitek T, Gates M, Pitotti C, Bartlett A, Patel J, Rahbar A, Forred W, Sontgerath JS, Clark JM. A Comparison of Headache Treatment in the Emergency Department: Prochlorperazine Versus Ketamine. Ann Emerg Med. 2018 Mar;71(3):369-377.e1. doi: 10.1016/j.annemergmed.2017.08.063. Epub 2017 Oct 14.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with University Medical Center of Southern Nevada via a Cooperative Research and Development Agreement. They are conducing the same study under a different IRB.
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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.
Christopher Pitotti, MD principal investigator
Mike O'Callaghan Federal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Compazine and Ketamine in people with Headache, run by Mike O'Callaghan Military Hospital 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 4 inclusion and 19 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: stopped early, as of the sponsor's last update on 4 Mar 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2024). 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?
Pain Score (time frame: 15 min, 30 min, 45 min, 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02735343, which also lists 2 linked publications.
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 4 Mar 2024.