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

NCT03407404 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2019-08-28

No results posted yet for this study

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.

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Conditions

  • Critical Illness

Interventions

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.

Sponsors & Collaborators

  • THRiVE

    collaborator UNKNOWN

  • Makerere University

    lead OTHER

Principal Investigators

  • Christine Namata, MBChB · Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-22
Primary Completion
2019-06-15
Completion
2019-07-30
FDA Drug
Yes

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03407404 on ClinicalTrials.gov