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

NCT05691088 | Unknown

• 1 other identifier: wm2022001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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).

Conditions

Acetaminophen,Mechanical Ventilation,Critically Ill Children

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation time

  an average of 5 days

Secondary Outcomes (1)

• Length of ICU stay time

  an average of 1 week

Study Arms (2)

Group A

EXPERIMENTAL

Paracetamol injection

Device: Paracetamol injection

Group B

NO INTERVENTION

Equivalent physiological saline

Interventions

Paracetamol injection DEVICE

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).

Group A

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• The Second Clinical Medical College of Jinan University: lead
• Kunming Children's Hospital: collaborator
• Shenzhen Windo Medical Technology Limited Company: collaborator

Study Sites (1)

Windo Medical

Shenzhen, Guangdong, 518020, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Second Clinical Medical College of Jinan University

Model Details: Clinical efficacy of acetaminophen in mechanical ventilation in children with new coronary pneumonia

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: December 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)