Clinical Efficacy of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
Primary Purpose
Acetaminophen,Mechanical Ventilation,Critically Ill Children
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Paracetamol injection
Sponsored by
About this trial
This is an interventional treatment trial for Acetaminophen,Mechanical Ventilation,Critically Ill Children
Eligibility Criteria
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.
Sites / Locations
- Windo MedicalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A
Group B
Arm Description
Paracetamol injection
Equivalent physiological saline
Outcomes
Primary Outcome Measures
Mechanical ventilation time
Secondary Outcome Measures
Length of ICU stay time
Full Information
NCT ID
NCT05691088
First Posted
January 10, 2023
Last Updated
January 10, 2023
Sponsor
The Second Clinical Medical College of Jinan University
Collaborators
Kunming Children's Hospital, Shenzhen Windo Medical Technology Limited Company
1. Study Identification
Unique Protocol Identification Number
NCT05691088
Brief Title
Clinical Efficacy of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
Official Title
To Evaluate the Clinical Efficacy of Standardized Use of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Clinical Medical College of Jinan University
Collaborators
Kunming Children's Hospital, Shenzhen Windo Medical Technology Limited Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acetaminophen,Mechanical Ventilation,Critically Ill Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Clinical efficacy of acetaminophen in mechanical ventilation in children with new coronary pneumonia
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Paracetamol injection
Arm Title
Group B
Arm Type
No Intervention
Arm Description
Equivalent physiological saline
Intervention Type
Device
Intervention Name(s)
Paracetamol injection
Intervention 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).
Primary Outcome Measure Information:
Title
Mechanical ventilation time
Time Frame
an average of 5 days
Secondary Outcome Measure Information:
Title
Length of ICU stay time
Time Frame
an average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Windo Medical
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
An-Min Hu
Phone
18026980789
Email
sci@wm.icu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Efficacy of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
We'll reach out to this number within 24 hrs