Status:
TERMINATED
Comparing Clinical Outcomes Between Ketamine-midazolam and Morphine-midazolam for Continous Sedation in ICU Patients.
Lead Sponsor:
Makerere University
Collaborating Sponsors:
THRiVE
Conditions:
Critical Illness
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
A prospective, double-blinded, multicenter randomized control trial. All critically ill patients above 12 years of age requiring continuous sedation for \>24hrs in the ICU will be screened and those m...
Detailed Description
165 participants shall be consecutively randomized into either sedation with ketamine-midazolam or morphine-midazolam group using a block sequence technique; group concealed in brown envelopes. Blindi...
Eligibility Criteria
Inclusion
- Age \>12years of age.
- Anticipated need for sedation for \>24hours.
Exclusion
- Hypertensive crisis i.e. sustained SBP \>200mmHg/DBP\>110mmHg
- Status epilepticus
- Ischemic heart disease and severe LV dysfunction
- Persistent tachyarrythmias
- History of mental illness
- Hypersensitivity to ketamine, morphine or midazolam.
- Tetanus -due to the muscle rigidity that may be caused by ketamine. Reasons for exclusions 1 to 4; Ketamine stimulates the sympathetic nervous system causing transient increase in myocardial work and blood pressure and has psychoactive effects
Key Trial Info
Start Date :
October 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2019
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03407404
Start Date
October 22 2017
End Date
July 30 2019
Last Update
August 28 2019
Active Locations (1)
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1
Mulago National Referral Hospital ICU
Kampala, Central Region, Uganda, 256