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

The Second Clinical Medical College of Jinan University

Status

Enrolling

Conditions

Acetaminophen,Mechanical Ventilation,Critically Ill Children

Treatments

Device: Paracetamol injection

Study type

Interventional

Funder types

Other

Identifiers

NCT05691088

wm2022001

Details and patient eligibility

About

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).

Enrollment

128 estimated patients

Sex

All

Ages

Under 16 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Inclusion criteria were body weight greater than 1500 g; and mechanically ventilated patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Exclusion criteria

Exclusion criteria were admitted with a tracheostomy in situ; extracorporeal membrane oxygenation treatment; neurologic dysfunction, hepatic dysfunction, or renal insufficiency; known allergy to or intolerance for paracetamol; and administration of paracetamol in the 24 hours prior to mechanical ventilation.