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Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

Primary Purpose

Analgesic, Enhanced Recovery After Surgery, Postoperative Pain

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Acetaminophen
Sterilized water
Sponsored by
Nanjing Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesic

Eligibility Criteria

1 Day - 12 Months (Child)All SexesDoes not accept healthy volunteers

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);

Sites / Locations

  • Children's Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

placebo group

Arm Description

After recovering and returning to the ward, acetaminophen (10mg/kg) was taken orally immediately; once every 6 hours, a total of 4 times.

The same amount of sterilized water was administered orally at the same time points.

Outcomes

Primary Outcome Measures

Using CRIES scale to assess the pain level at 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up

Secondary Outcome Measures

liver function
alanine aminotransferase, aspartate aminotransferase
renal function
urea and creatinine values
LOS
Length of stay after surgery
Using CRIES scale to assess the pain level at 1 hour after postoperative awakening
The pain score was evaluated 1 hour after Children wake up
Using CRIES scale to assess the pain level at 6 hours after postoperative awakening
The pain score was evaluated 6 hours after Children wake up
Using CRIES scale to assess the pain level at 18 hours after postoperative awakening
The pain score was evaluated 18 hours after Children wake up
Using CRIES scale to assess the pain level at 24 hours after postoperative awakening
The pain score was evaluated 24 hours after Children wake up
Using CRIES scale to assess the pain level at 36 hours after postoperative awakening
The pain score was evaluated 36 hours after Children wake up
Using CRIES scale to assess the pain level at 48 hours after postoperative awakening
The pain score was evaluated 48 hours after Children wake up
Using FLACC scale to assess the pain level at 1 hour after postoperative awakening
The pain score was evaluated 1 hour after Children wake up
Using FLACC scale to assess the pain level at 6 hours after postoperative awakening
The pain score was evaluated 6 hours after Children wake up
Using FLACC scale to assess the pain level at 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up
Using FLACC scale to assess the pain level at 18 hours after postoperative awakening
The pain score was evaluated 18 hours after Children wake up
Using FLACC scale to assess the pain level at 24 hours after postoperative awakening
The pain score was evaluated 24 hours after Children wake up
Using FLACC scale to assess the pain level at 36 hours after postoperative awakening
The pain score was evaluated 36 hours after Children wake up
Using FLACC scale to assess the pain level at 48 hours after postoperative awakening
The pain score was evaluated 48 hours after Children wake up
Using CHIPPS scale to assess the pain level at 1 hour after postoperative awakening
The pain score was evaluated 1 hour after Children wake up
Using CHIPPS scale to assess the pain level at 6 hours after postoperative awakening
The pain score was evaluated 6 hours after Children wake up
Using CHIPPS scale to assess the pain level at 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up
Using CHIPPS scale to assess the pain level at 18 hours after postoperative awakening
The pain score was evaluated 18 hours after Children wake up
Using CHIPPS scale to assess the pain level at 24 hours after postoperative awakening
The pain score was evaluated 24 hours after Children wake up
Using CHIPPS scale to assess the pain level at 36 hours after postoperative awakening
The pain score was evaluated 36 hours after Children wake up
Using CHIPPS scale to assess the pain level at 48 hours after postoperative awakening
The pain score was evaluated 48 hours after Children wake up

Full Information

First Posted
September 16, 2022
Last Updated
October 1, 2022
Sponsor
Nanjing Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05564819
Brief Title
Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants
Official Title
Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Under Enhanced Recovery After Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesic, Enhanced Recovery After Surgery, Postoperative Pain, Infant ALL, Acetaminophen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
After recovering and returning to the ward, acetaminophen (10mg/kg) was taken orally immediately; once every 6 hours, a total of 4 times.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
The same amount of sterilized water was administered orally at the same time points.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sterilized water
Intervention Description
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.
Primary Outcome Measure Information:
Title
Using CRIES scale to assess the pain level at 12 hours after postoperative awakening
Description
The pain score was evaluated 12 hours after Children wake up
Time Frame
12 hours after postoperative awakening
Secondary Outcome Measure Information:
Title
liver function
Description
alanine aminotransferase, aspartate aminotransferase
Time Frame
48 hours after surgery
Title
renal function
Description
urea and creatinine values
Time Frame
48 hours after surgery
Title
LOS
Description
Length of stay after surgery
Time Frame
30 days after surgery
Title
Using CRIES scale to assess the pain level at 1 hour after postoperative awakening
Description
The pain score was evaluated 1 hour after Children wake up
Time Frame
1 hour after postoperative awakening
Title
Using CRIES scale to assess the pain level at 6 hours after postoperative awakening
Description
The pain score was evaluated 6 hours after Children wake up
Time Frame
6 hours after postoperative awakening
Title
Using CRIES scale to assess the pain level at 18 hours after postoperative awakening
Description
The pain score was evaluated 18 hours after Children wake up
Time Frame
18 hours after postoperative awakening
Title
Using CRIES scale to assess the pain level at 24 hours after postoperative awakening
Description
The pain score was evaluated 24 hours after Children wake up
Time Frame
24 hours after postoperative awakening
Title
Using CRIES scale to assess the pain level at 36 hours after postoperative awakening
Description
The pain score was evaluated 36 hours after Children wake up
Time Frame
36 hours after postoperative awakening
Title
Using CRIES scale to assess the pain level at 48 hours after postoperative awakening
Description
The pain score was evaluated 48 hours after Children wake up
Time Frame
48 hours after postoperative awakening
Title
Using FLACC scale to assess the pain level at 1 hour after postoperative awakening
Description
The pain score was evaluated 1 hour after Children wake up
Time Frame
1 hour after postoperative awakening
Title
Using FLACC scale to assess the pain level at 6 hours after postoperative awakening
Description
The pain score was evaluated 6 hours after Children wake up
Time Frame
6 hours after postoperative awakening
Title
Using FLACC scale to assess the pain level at 12 hours after postoperative awakening
Description
The pain score was evaluated 12 hours after Children wake up
Time Frame
12 hours after postoperative awakening
Title
Using FLACC scale to assess the pain level at 18 hours after postoperative awakening
Description
The pain score was evaluated 18 hours after Children wake up
Time Frame
18 hours after postoperative awakening
Title
Using FLACC scale to assess the pain level at 24 hours after postoperative awakening
Description
The pain score was evaluated 24 hours after Children wake up
Time Frame
24 hours after postoperative awakening
Title
Using FLACC scale to assess the pain level at 36 hours after postoperative awakening
Description
The pain score was evaluated 36 hours after Children wake up
Time Frame
36 hours after postoperative awakening
Title
Using FLACC scale to assess the pain level at 48 hours after postoperative awakening
Description
The pain score was evaluated 48 hours after Children wake up
Time Frame
48 hours after postoperative awakening
Title
Using CHIPPS scale to assess the pain level at 1 hour after postoperative awakening
Description
The pain score was evaluated 1 hour after Children wake up
Time Frame
1 hour after postoperative awakening
Title
Using CHIPPS scale to assess the pain level at 6 hours after postoperative awakening
Description
The pain score was evaluated 6 hours after Children wake up
Time Frame
6 hours after postoperative awakening
Title
Using CHIPPS scale to assess the pain level at 12 hours after postoperative awakening
Description
The pain score was evaluated 12 hours after Children wake up
Time Frame
12 hours after postoperative awakening
Title
Using CHIPPS scale to assess the pain level at 18 hours after postoperative awakening
Description
The pain score was evaluated 18 hours after Children wake up
Time Frame
18 hours after postoperative awakening
Title
Using CHIPPS scale to assess the pain level at 24 hours after postoperative awakening
Description
The pain score was evaluated 24 hours after Children wake up
Time Frame
24 hours after postoperative awakening
Title
Using CHIPPS scale to assess the pain level at 36 hours after postoperative awakening
Description
The pain score was evaluated 36 hours after Children wake up
Time Frame
36 hours after postoperative awakening
Title
Using CHIPPS scale to assess the pain level at 48 hours after postoperative awakening
Description
The pain score was evaluated 48 hours after Children wake up
Time Frame
48 hours after postoperative awakening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Tang
Phone
+86 18262637795
Email
jietang1123@njmu.edu.cn
Facility Information:
Facility Name
Children's Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Tang, Master
Phone
+86 18262637795
Email
jietang1123@njmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

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