Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

July 9, 2024 updated by: Weibing Tang, Nanjing Children's Hospital

Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Under Enhanced Recovery After Surgery

Pain will bring early and long-term adverse reactions to infants. The investigators need to pay attention to whether there is pain in infants after surgery. Since infants cannot self-report pain,The investigators need to use appropriate pain assessment scale to evaluate the pain of these infants, so as to understand the status of postoperative pain in children. The result of pain score not only enables investigators to understand the pain status of children, but also helps investigators to give corresponding intervention and treatment according to the pain degree of children. Postoperative pain management is one of the core contents of ERAS. Effective pain management is beneficial to the early postoperative recovery of infants and reduces the adverse reactions caused by pain. Sveral studies have confirmed that the combination of acetaminophen and opioids could reduce the use of opioids after surgery. But even if opioid use is reduced, it still causes many side effects for children. This study evaluated the safety and efficacy of acetaminophen alone for postoperative analgesia in infants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Children's Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Informed consent was obtained from parents of children;
  • Infants aged 0-12 months;
  • Children who underwent abdominal and perineal surgery in the Department of Neonatal Surgery, Children's Hospital Affiliated to Nanjing Medical University and returned to the unaccompanied ward after removal of tracheal intubation.

Exclusion Criteria:

  • No informed consent was obtained from parents;
  • known allergy or intolerance to acetaminophen;
  • Children with liver function impairment (alanine aminotransferase/aspartate aminotransferase (ALAT/ASAT) more than three times the reference value;
  • Children with renal insufficiency (urea and creatinine values exceeding the upper limit of reference values);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group
After recovering and returning to the ward, acetaminophen (10mg/kg) was taken orally immediately; once every 6 hours, a total of 4 times.
Drug: Acetaminophen
When the infants woke up after surgery and were transported back to the ward, they were randomly divided into two groups immediately. The intervention group was given oral acetaminophen, once every 6 hours, for a total of 4 times.
Placebo Comparator: placebo group
The same amount of sterilized water was administered orally at the same time points.
Drug: Sterilized water
When the infants woke up after surgery and were transported back to the ward, they were randomly divided into two groups immediately. The control group was given sterilized water, once every 6 hours, for a total of 4 times.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Using CRIES scale to assess the pain level at 12 hours after postoperative awakening
Time Frame: 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up
12 hours after postoperative awakening

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
liver function
Time Frame: 48 hours after surgery
alanine aminotransferase, aspartate aminotransferase
48 hours after surgery
renal function
Time Frame: 48 hours after surgery
urea and creatinine values
48 hours after surgery
LOS
Time Frame: 30 days after surgery
Length of stay after surgery
30 days after surgery
Using CRIES scale to assess the pain level at 1 hour after postoperative awakening
Time Frame: 1 hour after postoperative awakening
The pain score was evaluated 1 hour after Children wake up
1 hour after postoperative awakening
Using CRIES scale to assess the pain level at 6 hours after postoperative awakening
Time Frame: 6 hours after postoperative awakening
The pain score was evaluated 6 hours after Children wake up
6 hours after postoperative awakening
Using CRIES scale to assess the pain level at 18 hours after postoperative awakening
Time Frame: 18 hours after postoperative awakening
The pain score was evaluated 18 hours after Children wake up
18 hours after postoperative awakening
Using CRIES scale to assess the pain level at 24 hours after postoperative awakening
Time Frame: 24 hours after postoperative awakening
The pain score was evaluated 24 hours after Children wake up
24 hours after postoperative awakening
Using CRIES scale to assess the pain level at 36 hours after postoperative awakening
Time Frame: 36 hours after postoperative awakening
The pain score was evaluated 36 hours after Children wake up
36 hours after postoperative awakening
Using CRIES scale to assess the pain level at 48 hours after postoperative awakening
Time Frame: 48 hours after postoperative awakening
The pain score was evaluated 48 hours after Children wake up
48 hours after postoperative awakening
Using FLACC scale to assess the pain level at 1 hour after postoperative awakening
Time Frame: 1 hour after postoperative awakening
The pain score was evaluated 1 hour after Children wake up
1 hour after postoperative awakening
Using FLACC scale to assess the pain level at 6 hours after postoperative awakening
Time Frame: 6 hours after postoperative awakening
The pain score was evaluated 6 hours after Children wake up
6 hours after postoperative awakening
Using FLACC scale to assess the pain level at 12 hours after postoperative awakening
Time Frame: 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up
12 hours after postoperative awakening
Using FLACC scale to assess the pain level at 18 hours after postoperative awakening
Time Frame: 18 hours after postoperative awakening
The pain score was evaluated 18 hours after Children wake up
18 hours after postoperative awakening
Using FLACC scale to assess the pain level at 24 hours after postoperative awakening
Time Frame: 24 hours after postoperative awakening
The pain score was evaluated 24 hours after Children wake up
24 hours after postoperative awakening
Using FLACC scale to assess the pain level at 36 hours after postoperative awakening
Time Frame: 36 hours after postoperative awakening
The pain score was evaluated 36 hours after Children wake up
36 hours after postoperative awakening
Using FLACC scale to assess the pain level at 48 hours after postoperative awakening
Time Frame: 48 hours after postoperative awakening
The pain score was evaluated 48 hours after Children wake up
48 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 1 hour after postoperative awakening
Time Frame: 1 hour after postoperative awakening
The pain score was evaluated 1 hour after Children wake up
1 hour after postoperative awakening
Using CHIPPS scale to assess the pain level at 6 hours after postoperative awakening
Time Frame: 6 hours after postoperative awakening
The pain score was evaluated 6 hours after Children wake up
6 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 12 hours after postoperative awakening
Time Frame: 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up
12 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 18 hours after postoperative awakening
Time Frame: 18 hours after postoperative awakening
The pain score was evaluated 18 hours after Children wake up
18 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 24 hours after postoperative awakening
Time Frame: 24 hours after postoperative awakening
The pain score was evaluated 24 hours after Children wake up
24 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 36 hours after postoperative awakening
Time Frame: 36 hours after postoperative awakening
The pain score was evaluated 36 hours after Children wake up
36 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 48 hours after postoperative awakening
Time Frame: 48 hours after postoperative awakening
The pain score was evaluated 48 hours after Children wake up
48 hours after postoperative awakening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCH202207156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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