NCT03407404

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

Ketamine-Midazolam Versus Morphine-Midazolam for Continous Patient Sedation in Intensive Care Units in Uganda. A Randomised Controlled Trial.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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. .

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Ketamine-Midazolam	Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.
COMBINATION_PRODUCT	Morphine -Midazolam	Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.

Timeline

• Start date: 2017-10-22
• Primary completion: 2019-06-15
• Completion: 2019-07-30
• First posted: 2018-01-23
• Last updated: 2019-08-28

Locations

1 site across 1 country: Uganda

Regulatory

• FDA-regulated drug study