NCT03879564 is a Phase 4 clinical trial of Ketamine in Critically Ill, sponsored by Mahidol University.

Who is sponsoring NCT03879564?

NCT03879564 is sponsored by Mahidol University.

What drugs are being tested in NCT03879564?

Interventions in NCT03879564: Ketamine, Normal saline.

What condition does NCT03879564 study?

NCT03879564 studies Critically Ill, Pain, Postoperative.

Is NCT03879564 still recruiting?

NCT03879564 is currently completed. Last updated 15 July 2024.

Last reviewed 2024-07-15 · How we verify

NCT03879564

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ketamine-fentanyl VS Fentanyl for Analgosedation in SICU

Completed Phase 4 Last updated 15 July 2024

What this trial tests

Phase 4 trial testing Ketamine in Critically Ill in 118 participants. Completed in 30 June 2024.

Timeline

5 April 2019

Primary endpoint
30 December 2021

30 June 2024

Quick facts

Lead sponsor	Mahidol University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	118
Start date	5 April 2019
Primary completion	30 December 2021
Estimated completion	30 June 2024
Sites	1 location across Thailand

Drugs / interventions tested

Ketamine (ketamine) — full drug profile →
Normal saline

Conditions studied

Critically Ill — all drugs for Critically Ill →
Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Mahidol University

Who can join

18 and older, any sex, with Critically Ill or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ketamine

Trials testing the same drug.

NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
NCT06963294 — Ketamine and Dexmedetomidine for Delirium in Joint Arthroplasty · NA · not yet recruiting
NCT07294092 — Ketamine and Propofol NeuroImaging · EARLY_PHASE1 · recruiting
NCT07197684 — Ultrasound Guided Pecs Block and Ketamine Infusion for Preventing Chronic Pain in Patients Undergoing Breast Cancer Surg · NA · not yet recruiting
NCT06231563 — Ketamine for Veterans With Parkinson's Disease · Phase 2 · recruiting

Other recruiting trials for Critically Ill

Currently open trials in the same condition.

NCT07222007 — Induction Agent Choice With Early Mortality and Prognostic Outcomes in Critically Ill Patients · recruiting
NCT07143695 — Parasternal Intercostal Muscle Thickening as an Additive Weaning Criterion · NA · recruiting
NCT06473844 — Efficacy of SGLT2 Inhibitors in Adults With Sepsis · NA · recruiting
NCT05055830 — Opportunistic PK/PD Trial in Critically Ill Children (OPTIC) · recruiting
NCT05112328 — The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding · NA · recruiting

Other Mahidol University trials

Trials by the same sponsor.

NCT07568496 — Greater Occipital Nerve Block for Migraine With Medication Overuse Headache · NA · not yet recruiting
NCT07407400 — Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients · Phase 4 · not yet recruiting
NCT07378501 — Thai Version of the Pediatric Quality of Recovery Score (PedSQoR): Translation and Psychometric Validation Study · not yet recruiting
NCT07438301 — Septic Shock Hemodynamic Respond to Volume Resuscitation Versus Vasopressor Administration · not yet recruiting
NCT07390006 — Enabling Patient-Reported Outcomes Through Innovative Care - ACS (EPIC-ACS) · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03879564 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mahidol University
Last refreshed: 15 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03879564.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing