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

Not Applicable

Recruiting

• Conditions: Acetaminophen,Mechanical Ventilation,Critically Ill Children
• Interventions: Device: Paracetamol injection

• Registration Number: NCT05691088
• Lead Sponsor: The Second Clinical Medical College of Jinan University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Status Verified: 2023-01
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Last Update Submitted: 2023-01-10
• Study First Posted: 2023-01-19
• Last Update Posted: 2023-01-19
• Primary Completion: 2023-05-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Paracetamol injection	Paracetamol injection

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation time	an average of 5 days

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay time	an average of 1 week

Trial Locations

Locations (1)

Windo Medical; 🇨🇳 Shenzhen, Guangdong, China