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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05691088
Enrollment
128
Registered
2023-01-19
Start date
2022-12-15
Completion date
2023-12-15
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acetaminophen,Mechanical Ventilation,Critically Ill Children

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).

Interventions

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).

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
0 Years to 16 Years
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

*

Design outcomes

Primary

MeasureTime frame
Mechanical ventilation timean average of 5 days

Secondary

MeasureTime frame
Length of ICU stay timean average of 1 week

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026