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

Sponsor

The Second Clinical Medical College of Jinan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05691088

Collaborator

Kunming Children's Hospital (Other), Shenzhen Windo Medical Technology Limited Company (Other)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Acetaminophen,Mechanical Ventilation,Critically Ill Children	Device: Paracetamol injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Clinical efficacy of acetaminophen in mechanical ventilation in children with new coronary pneumoniaClinical efficacy of acetaminophen in mechanical ventilation in children with new coronary pneumonia

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

To Evaluate the Clinical Efficacy of Standardized Use of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia

Actual Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

May 15, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A Paracetamol injection	Device: Paracetamol injection 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).
No Intervention: Group B Equivalent physiological saline

Arm

Intervention/Treatment

Experimental: Group A

Paracetamol injection

Device: Paracetamol injection

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).

No Intervention: Group B

Equivalent physiological saline

Outcome Measures

Primary Outcome Measures

Mechanical ventilation time [an average of 5 days]

Secondary Outcome Measures

Length of ICU stay time [an average of 1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Windo Medical	Shenzhen	Guangdong	China	518020

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hu Anmin, The Second Clinical Medical College of Jinan University, The Second Clinical Medical College of Jinan University

ClinicalTrials.gov Identifier:

NCT05691088

Other Study ID Numbers:

wm2022001

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pneumonia

Critical Illness

Acetaminophen

Study Results

No Results Posted as of Jan 19, 2023