Phase 4
N=54
The CHECK Trial: A Comparison of Headache Treatment in the ED: Compazine Versus Ketamine
Headache
Bottom Line
View on ClinicalTrials.gov: NCT02657031 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Headache Following Intervention — 63.5; 43.5 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prochlorperazine (Drug); Ketamine (Drug); Diphenhydramine (Drug); Ondansetron (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Medical Center of Southern Nevada
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Headache Following Intervention |
63.5; 43.5 | — |
| SECONDARY Anxiety |
33.7; 21.2 | — |
| SECONDARY Nausea |
38.9; 22.9 | — |
| SECONDARY The Number of Participants Experiencing Vomiting |
2; 3 | — |
| SECONDARY The Number of Patients Experiencing Restlessness |
3; 3 | — |
Summary
This study compares the efficacy of low dose Ketamine versus Compazine for the control of headache in patients presenting to the Emergency Department.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02657031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.