Clinical trial NCT03407404: Comparing Clinical Outcomes Between Ketamine-midazolam and Morphine-midazolam for Continous Sedation in ICU Patients.
Official title: Ketamine-Midazolam Versus Morphine-Midazolam for Continous Patient Sedation in Intensive Care Units in Uganda. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Critical Illness
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: THRiVE
First posted: 2018-01-23
Enrollment: 124
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either receive ketamine-midazolam or morphine-midazolam for continous sedation at enrollment, then followed up for outcomes.
Primary purpose: TREATMENT

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 meeting selection criteria (and consented) will be enrolled into the study.

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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. Blinding will be at patient/next of kin level as well as investigator/data collector level.

Enrolled subjects shall be followed up for treatment history, co-morbidities and related data will be collected, results analyzed and study findings will be availed to ICU physicians and Ministry of health to guide treatment considerations and for health care planning.

Data shall be collected using a standardized questionnaire by trained research assistants. It will be double entered into Epidata and exported to STATA version 12.0 for analysis. Continuous variables will be expressed as means and standard deviations, while categorical data will be expressed as frequencies with their respective percentages. Linear regression and logistic regression used to analyse primary outcomes, as well as multivariate analysis to detect associations.

Eligibility criteria: Inclusion Criteria:

1. Age \>12years of age.
2. Anticipated need for sedation for \>24hours.

Exclusion Criteria:

1. Hypertensive crisis i.e. sustained SBP \>200mmHg/DBP\>110mmHg
2. Status epilepticus
3. Ischemic heart disease and severe LV dysfunction
4. Persistent tachyarrythmias
5. History of mental illness
6. Hypersensitivity to ketamine, morphine or midazolam.
7. 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

Primary outcomes:
measure: duration of mechanical ventilation
timeFrame: 14 days
measure: incidence of hypotension
timeFrame: 14 days
measure: incidence of delirium
timeFrame: 14 days
Secondary outcomes:
measure: ICU length of stay
timeFrame: 14 days
measure: mortality rate
timeFrame: within 14 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago National Referral Hospital ICU
state: Central
Study officials:
affiliation: Makerere University
name: Christine Namata, MBChB
role: PRINCIPAL_INVESTIGATOR
References: