Comparing Clinical Outcomes Between Ketamine-midazolam and Morphine-midazolam for Continous Sedation in ICU Patients. (KeMiMof)

Makerere University

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Critical Illness

Treatments: Combination Product: Morphine -Midazolam; Combination Product: Ketamine-Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03407404

2015/HD07/1275U

Details and patient eligibility

About

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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Full 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.

Enrollment: 124 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Ketamine-midazolam

Experimental group

Description:

Continous intravenous sedation with a colorless drug mixture in 50ml syringe containing 900mg ketamine and 36mg midazolam.

Treatment:

Combination Product: Ketamine-Midazolam

Morphine-Midazolam

Active Comparator group

Description:

Continous intravenous sedation with a colourless drug mixture in 50ml syringes containing 54mg morphine and 36mg midazolam.

Treatment:

Combination Product: Morphine -Midazolam