Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02735343 |
| Other study ID # |
FWH20160057H |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
August 2016 |
| Est. completion date |
May 2017 |
Study information
| Verified date |
February 2024 |
| Source |
Mike O'Callaghan Military Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
