Critical Illness Clinical Trial
Official title:
Ketamine-Midazolam Versus Morphine-Midazolam for Continous Patient Sedation in Intensive Care Units in Uganda. A Randomised Controlled Trial.
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.
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