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

Phase 3TerminatedNCT03407404

Makerere University124 enrolled

Overview

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. .

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

124

Conditions

Critical Illness

Interventions

Ketamine-MidazolamCOMBINATION_PRODUCT

Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.

Morphine -MidazolamCOMBINATION_PRODUCT

Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

Mulago National Referral Hospital ICU

Kampala, Central Region, Uganda

Outcomes

Primary Outcomes

duration of mechanical ventilation

in hours from start of mechanical ventialtion

Time frame: 14 days

incidence of hypotension

incidence of hypotension requiring vasopressor support.

Time frame: 14 days

incidence of delirium

assessed daily with the CAM-ICU score

Time frame: 14 days

Secondary Outcomes

ICU length of stay

length of stay in the intensive care unit from enrollment.

Time frame: 14 days

mortality rate

number of deaths in each study arm

Time frame: within 14 days

Data from ClinicalTrials.gov

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