Headache
Conditions
Brief 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.
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.
Interventions
Compazine 10mg with diphenhydramine 25 mg IV
Ketamine 0.3 mg/kg along with ondansetron 4 mg IV
Sponsors
Study design
Eligibility
Inclusion criteria
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY. Inclusion Criteria * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment Arm compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously
Compazine: Compazine 10mg with diphenhydramine 25 mg IV | 1 |
| Research Arm Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously
Ketamine: Ketamine 0.3 mg/kg along with ondansetron 4 mg IV | 4 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | screen fail | 0 | 2 |
Baseline characteristics
| Characteristic | Standard Treatment Arm | Research Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
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.
Time frame: 15 min, 30 min, 45 min, 60 min
Population: This study was terminated early due to the study becoming unnecessary due to findings in another trial. Raw data were collected for the 3 subjects who completed the study (2 screen failed). Raw data is reported.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Standard Treatment Arm | Pain Score | Headache Score 0 minutes | 39 score on a scale |
| Standard Treatment Arm | Pain Score | headache score 15 minutes | 18 score on a scale |
| Standard Treatment Arm | Pain Score | headache score 30 minutes | 8 score on a scale |
| Research Arm | Pain Score | headache score 15 minutes | 16.5 score on a scale |
| Research Arm | Pain Score | headache score 60 minutes | 13 score on a scale |
| Research Arm | Pain Score | headache score 30 minutes | 19 score on a scale |
| Research Arm | Pain Score | Headache Score 0 minutes | 74 score on a scale |
| Research Arm | Pain Score | headache score 45 minutes | 10 score on a scale |