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Recruiting
NCT05691088
Clinical Efficacy of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
Conditions: Acetaminophen,Mechanical Ventilation,Critically Ill Children
Sex: All
Ages: 0 Years – 16 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 128
Sponsor: The Second Clinical Medical College of Jinan University
Location: China
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).
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.
Source: ClinicalTrials.gov (NCT05691088). StuddyBuddy aggregates publicly available trial information.