drugset / Trial / NCT03879564

Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU

NCT03879564 ↗

Phase 4 Completed 118 enrolled Mahidol University
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blinded study to evaluate the analgosedative effect of ketamine in a surgical intensive care unit. The patients who will receive continuous fentanyl infusion for either pain control or sedation will be recruited in this trial. Fentanyl will be titrated with initial loading doses of 20 mcg until the numeral rating scale(NRS) less than 4 or critical care pain observation tool (CPOT) less than 3 or Richmond agitation sedation score (RASS) -2-0. Then the patients will be randomised in to receive saline infusion in control group (Group C) or ketamine infusion in ketamine group (Group K). Ketamine will be administered with an initial bolus of 0.3 mg/kg followed by a perfusion of1.5 mcg/kg/min during the first 48 h. The dose of fentanyl will be protocolized adjusted according to NRS or CPOT or RASS. We tested the research hypothesis that low-doseketamine infusion is associated with a reduced fentanyl dose without increased vulnerability to its psychotropic effects.

Timeline

Start
2019-04-05
Primary completion
2021-12-30
Completion
2024-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 1.5 ug/kg Intravenous

Indications

No indication recorded.