The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine
- Conditions
- Headache
- Interventions
- Registration Number
- NCT02657031
- Lead Sponsor
- University Medical Center of Southern Nevada
- Brief Summary
This study compares the efficacy of low dose Ketamine versus Compazine for the control of headache in patients presenting to the Emergency Department.
- Detailed Description
After enrollment, each patient will randomized either to the standard treatment arm to receive prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV, OR to the study arm to receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. The diphenhydramine or ondansetron will be administered first, and immediately afterward the prochlorperazine or Ketamine will be administered. The prochlorperazine or Ketamine will be diluted in saline so that the total volume is 5 mL, and will be administered over 2 minutes. The diphenhydramine will be diluted in saline so that it is 2 mL (the same volume as the ondansetron). Both groups will also receive a 500 mL normal saline bolus after the study medications are administered. The ED pharmacist will be responsible for preparing the medications, using a double-blind protocol. He or she will record which arm the patient was randomized to. Only the pharmacist will have access to the randomization records and will not reveal the randomization until the end of the study. Emergency providers will be instructed not to administer any rescue medications for at least 30 minutes. The electronic medical record order will read "randomized study medication" (for the Ketamine or prochlorperazine) and "randomized add-on medication" (for the ondansetron or diphenhydramine).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Age 18 to 65 years
- Temperature < 100.4° F
- Diastolic Blood Pressure <104 mm Hg
- Normal neurological exam and mormal mental status
- 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 onset of the headache
- Weight more than 150 kg or less than 40 kg.
- Known allergy to one of the study drugs.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Normal Saline This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus Study Arm Normal Saline This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus. Control Arm Prochlorperazine This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus Control Arm Diphenhydramine This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus Study Arm Ketamine This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus. Study Arm Ondansetron This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus.
- Primary Outcome Measures
Name Time Method Headache Following Intervention 0-60 minutes Reduction in 100 mm Visual Analog Scale (VAS) Score. Positive values represent a reduction in headache severity. The maximum possible change in VAS score is 100 mm, representing the complete relief of a maximally severe headache. A change of 0 mm corresponds to no change in headache severity, and a negative value indicates worsening of the headache after the medication.
- Secondary Outcome Measures
Name Time Method Nausea 0-60 minutes Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum nausea. A change of 0 mm corresponds to no change in nausea level, and a negative value indicates worsening of the nausea after the medication.
The Number of Participants Experiencing Vomiting 0-60 minutes Yes/No
Anxiety 0-60 minutes Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum anxiety. A change of 0 mm corresponds to no change in anxiety level, and a negative value indicates worsening of the anxiety after the medication.
The Number of Patients Experiencing Restlessness 0-60 minutes Yes/No
Trial Locations
- Locations (1)
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States