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The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine

The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine. A Multi-Center, Randomized, Double-Blind, Clinical Control Trial

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02735343
Acronym
Check
Enrollment
5
Registered
2016-04-12
Start date
2016-08-31
Completion date
2017-05-31
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache

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

DRUGKetamine

Ketamine 0.3 mg/kg along with ondansetron 4 mg IV

Sponsors

Mike O'Callaghan Military Hospital
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Pain Score15 min, 30 min, 45 min, 60 minSubjects 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

ArmCount
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
Total5

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studyscreen fail02

Baseline characteristics

CharacteristicStandard Treatment ArmResearch ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
1 Participants4 Participants5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants3 Participants3 Participants
Sex: Female, Male
Female
1 Participants3 Participants4 Participants
Sex: Female, Male
Male
0 Participants1 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 20 / 3
other
Total, other adverse events
0 / 20 / 3
serious
Total, serious adverse events
0 / 20 / 3

Outcome results

Primary

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.

ArmMeasureGroupValue (MEAN)
Standard Treatment ArmPain ScoreHeadache Score 0 minutes39 score on a scale
Standard Treatment ArmPain Scoreheadache score 15 minutes18 score on a scale
Standard Treatment ArmPain Scoreheadache score 30 minutes8 score on a scale
Research ArmPain Scoreheadache score 15 minutes16.5 score on a scale
Research ArmPain Scoreheadache score 60 minutes13 score on a scale
Research ArmPain Scoreheadache score 30 minutes19 score on a scale
Research ArmPain ScoreHeadache Score 0 minutes74 score on a scale
Research ArmPain Scoreheadache score 45 minutes10 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026