Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

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: Recruiting
• Conditions: Postoperative Pain; Infant ALL; Enhanced Recovery After Surgery; Acetaminophen; Analgesic
• Intervention / Treatment: Drug: Acetaminophen; Drug: Sterilized water

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jie Tang; Phone Number: +86 18262637795; Email: jietang1123@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Children's Hospital of Nanjing Medical University
      • Contact: Jie Tang, Master; Phone Number: +86 18262637795; Email: jietang1123@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	12 hours after postoperative awakening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
liver function	alanine aminotransferase, aspartate aminotransferase	48 hours after surgery
renal function	urea and creatinine values	48 hours after surgery
LOS	Length of stay after surgery	30 days 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	1 hour after postoperative awakening
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	6 hours after postoperative awakening
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	18 hours after postoperative awakening
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	24 hours after postoperative awakening
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	36 hours after postoperative awakening
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	48 hours after postoperative awakening
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	1 hour after postoperative awakening
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	6 hours after postoperative awakening
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	12 hours after postoperative awakening
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	18 hours after postoperative awakening
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	24 hours after postoperative awakening
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	36 hours after postoperative awakening
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	48 hours after postoperative awakening
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	1 hour after postoperative awakening
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	6 hours after postoperative awakening
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	12 hours after postoperative awakening
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	18 hours after postoperative awakening
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	24 hours after postoperative awakening
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	36 hours after postoperative awakening
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	48 hours after postoperative awakening

Collaborators and Investigators

• Sponsor: Nanjing Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2022
• Primary Completion (ANTICIPATED): May 15, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: October 1, 2022
• First Posted (ACTUAL): October 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID 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