NCT05691088

Clinical Efficacy of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia

Status unknown NA Last updated 19 January 2023

What this trial tests

NA trial testing Paracetamol injection in Acetaminophen,Mechanical Ventilation,Critically Ill Children in 128 participants. Status unknown.

Timeline

15 December 2022

Primary endpoint
15 May 2023

15 December 2023

Quick facts

Lead sponsor	The Second Clinical Medical College of Jinan University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	128
Start date	15 December 2022
Primary completion	15 May 2023
Estimated completion	15 December 2023
Sites	1 location across China

Drugs / interventions tested

• Paracetamol injection

Conditions studied

• Acetaminophen,Mechanical Ventilation,Critically Ill Children — all drugs for Acetaminophen,Mechanical Ventilation,Critically Ill Children →

Sponsor

The Second Clinical Medical College of Jinan University

Who can join

Adults 0 to 16, any sex, with Acetaminophen,Mechanical Ventilation,Critically Ill Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients were randomized to receive either paracetamol during mechanical ventilation. When patients were randomized to receive paracetamol (40 mg/kg per day in 4 doses), a placebo infusion of normal saline was administered continuously at the same rate as an equivalent infusion. Placebos could not be distinguished from the active study drug in color, odor, or viscosity.

In both study groups, IMV was maintained with sufentanil (0-0.2 mcg/kg/h), propofol (0-4 mg/kg/h), and dexmedetomidine (0-1 mcg/kg/h). Assessment of sedation levels by the bedside nurse using the FLACC pain scale to determine if the child is adequately comfortable or in need of more or less medication to maintain adequate ventilation. Assessment of sedation levels by the bedside nurse using the FLACC pain scale (every 6 hours as a minimum time interval).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.