Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

Phase 1

Completed

• Conditions: Infant ALL; Acetaminophen; Analgesic; Enhanced Recovery After Surgery; Postoperative Pain
• Interventions: Drug: Sterilized water; Drug: Acetaminophen

• Registration Number: NCT05564819
• Lead Sponsor: Nanjing Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-14
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-10-01
• Study First Posted: 2022-10-04
• Primary Completion: 2023-05-15
• Study Completion: 2023-07-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Sterilized water	The same amount of sterilized water was administered orally at the same time points.
Treatment group	Acetaminophen	After recovering and returning to the ward, acetaminophen (10mg/kg) was taken orally immediately; once every 6 hours, a total of 4 times.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
LOS	30 days after surgery	Length of stay after surgery
Using CRIES scale to assess the pain level at 6 hours after postoperative awakening	6 hours after postoperative awakening	The pain score was evaluated 6 hours after Children wake up
liver function	48 hours after surgery	alanine aminotransferase, aspartate aminotransferase
renal function	48 hours after surgery	urea and creatinine values
Using CRIES scale to assess the pain level at 1 hour after postoperative awakening	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 18 hours after postoperative awakening	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 36 hours after postoperative awakening	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 18 hours after postoperative awakening	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	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	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	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	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	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	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	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	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	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	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	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	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	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 24 hours after postoperative awakening	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 48 hours after postoperative awakening	48 hours after postoperative awakening	The pain score was evaluated 48 hours after Children wake up

Trial Locations

Locations (1)

Children's Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China