Critical Illness
Conditions
Brief 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.
Interventions
COMBINATION_PRODUCTKetamine-Midazolam
Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.
COMBINATION_PRODUCTMorphine -Midazolam
Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.
Sponsors
THRiVE
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Drugs will be premixed and coded for ketamine-midazolam or morphine-midazolam. The colorless drug mixture shall be provided to the attending physician to start the infusion at 2ml/hour and to be titrated to the desired level of sedation. The investigator and participant will be unaware of which group a certain patient is under.
Intervention model description
Patients will be randomized to either receive ketamine-midazolam or morphine-midazolam for continous sedation at enrollment, then followed up for outcomes.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of mechanical ventilation | 14 days | in hours from start of mechanical ventialtion |
| incidence of hypotension | 14 days | incidence of hypotension requiring vasopressor support. |
| incidence of delirium | 14 days | assessed daily with the CAM-ICU score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU length of stay | 14 days | length of stay in the intensive care unit from enrollment. |
| mortality rate | within 14 days | number of deaths in each study arm |
Countries
Uganda
Outcome results
None listed