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
Intervention / Treatment
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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 |
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Status: | Completed |
Study results: | No Results Available |
Age: | 18 Years to 65 Years |
Enrollment: | 54 (ACTUAL) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Treatment |
MaskingDOUBLE:
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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
Location
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 |
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Minimum Age: | 18 |
Maximum Age: | 65 |
Age Groups: | Adult / Older Adult |
Healthy Volunteers: | Yes |
* 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 |
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Other IDs: | EM 2015.13 |
Study URL: | https://clinicaltrials.gov/study/NCT02657031 |