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.
The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine
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.
Intervention / Treatment
Double-Blind Randomized Clinical Control Trial
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Prochlorperazine (DRUG)prochlorperazine 10 mg IV
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Ketamine (DRUG)Ketamine 0.3 mg/kg IV
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Diphenhydramine (DRUG)Diphenhydromine 25 mg IV
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Ondansetron (DRUG)Ondansetron 4 mg IV
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Normal saline (DRUG)Normal Saline 500 cc IV Bolus
Condition or Disease
- Headache
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 54 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
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Clinical Trial Dates
| Start date: | Mar 17, 2016 | ACTUAL |
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| Primary Completion: | Mar 21, 2017 | ACTUAL |
| Completion Date: | Mar 21, 2017 | ACTUAL |
| Study First Posted: | Jan 15, 2016 | ESTIMATED |
| Results First Posted: | Dec 11, 2017 | ACTUAL |
| Last Updated: | Dec 07, 2017 |
Sponsors / Collaborators
Lead Sponsor:
University Medical Center of Southern Nevada
Lead sponsor is responsible party
Responsible Party:
N/A
Location
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).
Participant Groups
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This arm uses standard of care treatment of prochlorperazine 10 mg IV along with diphenhydramine 25 mg IV plus Normal Sailine 500 cc bolus
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This arm uses stud drug regime of Ketamine 0.3 mg/kg along with Ondansetron 4 mg IV plus Normal Saline 500 cc bolus.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Age 18 to 65 years
* Temperature \< 100.4° F
* Diastolic Blood Pressure \<104 mm Hg
* Normal neurological exam and mormal 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 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
* Age 18 to 65 years
* Temperature \< 100.4° F
* Diastolic Blood Pressure \<104 mm Hg
* Normal neurological exam and mormal 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 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
Primary Outcomes
Secondary Outcomes
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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.
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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.
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Yes/No
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Yes/No
More Details
| NCT Number: | NCT02657031 |
|---|---|
| Other IDs: | EM 2015.13 |
| Study URL: | https://clinicaltrials.gov/study/NCT02657031 |
Last updated: Sep 29, 2023