Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT03639558
Eligibility Criteria:
Inclusion Criteria:
* Patient will be eligible if (1) requiring emergency acute intramuscular sedation because of disturbed and dangerous behaviour and (2) if the clinician is uncertain of the benefits between haloperidol plus promethazine vs haloperidol plus promethazine plus chlorpromazine.
* Gender - both male and female
* Age (18-64)
* Clinician is unaware on the effects of either treatment interventions
Exclusion Criteria:
* If the clinician KNOWS one treatment has benefit over another for a particular person
* If the clinician is aware of a contra-indication of one of the treatments
* If there is an Advanced Directive expressing a wish for one or other, or another treatment in the emergency setting.
* If the clinician does not want to undertake for both personal and professional reasons.
* If the participant is known to be allergic to one or more of the interventions
* Already randomized
* Already sedated
* Accompanying person (Friend/Family/Police Officer) refuses patient trial entry
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03639558
Study Brief:
Protocol Section:
NCT03639558