Acetaminophen,Mechanical Ventilation,Critically Ill ChildrenNCT05691088
Clinical Efficacy of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
A study testing Paracetamol injection in people with Acetaminophen,Mechanical Ventilation,Critically Ill Children, run by The Second Clinical Medical College of Jinan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Acetaminophen,Mechanical Ventilation,Critically Ill Children
- What is being tested?
- Paracetamol injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Windo Medical
Shenzhen, Guangdong, 518020
An-Min Hu, 18026980789, sci@wm.icu
About this study
Official title: To Evaluate the Clinical Efficacy of Standardized Use of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
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).
- Being tested
- Paracetamol injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol injectionDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Paracetamol injection Receives: Device: Paracetamol injection |
| Group B | No intervention | Equivalent physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation time
Measured: an average of 5 days
Secondary outcomes (1)
Length of ICU stay time
Measured: an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start15 Dec 2022
- Primary completion15 May 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetaminophen,Mechanical Ventilation,Critically Ill ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical efficacy of acetaminophen in mechanical ventilation in children with new coronary pneumonia
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Clinical Medical College of Jinan University
- Sponsor type
- University, hospital or other
- Collaborators
- Kunming Children's Hospital, Shenzhen Windo Medical Technology Limited Company
- Responsible party
- Principal investigator, Hu Anmin, The Second Clinical Medical College of Jinan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691088
- Sponsor's protocol ID
- wm2022001
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Clinical Efficacy of Standardized Use of Acetaminophen in Mechanical Ventilation in Children With New Coronary Pneumonia
- ClinicalTrials.gov ID
- NCT05691088
- Acronym / sponsor ID
- wm2022001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The Second Clinical Medical College of Jinan UniversityUniversity, hospital or other
- Collaborators
- Kunming Children's Hospital, Shenzhen Windo Medical Technology Limited Company
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical efficacy of acetaminophen in mechanical ventilation in children with new coronary pneumonia
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Paracetamol injectionParacetamol injection |
| Group B | No intervention | –Equivalent physiological saline |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol injectionPatients 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). | Device | Group A |
Primary outcome
Mechanical ventilation time
Time frame: an average of 5 days
1 secondary outcome
Length of ICU stay time
Time frame: an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol injection in people with Acetaminophen,Mechanical Ventilation,Critically Ill Children, run by The Second Clinical Medical College of Jinan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical ventilation time (time frame: an average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.