A Phase 2/3 interventional study of Ketamine-Midazolam and Morphine -Midazolam in Critical Illness, sponsored by Makerere University. Terminated at 1 site in Uganda. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Makerere University · Phase 2/3, Interventional, and Treatment
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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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.
1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.
This study's enrollment of 124 is above the median of 90 across 926 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Continous intravenous sedation with a colorless drug mixture in 50ml syringe containing 900mg ketamine and 36mg midazolam.
Combination Product: Ketamine-Midazolam
Continous intravenous sedation with a colourless drug mixture in 50ml syringes containing 54mg morphine and 36mg midazolam.
Combination Product: Morphine -Midazolam
Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.
Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.
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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Jun 2019, 19 months.
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This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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