Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

NCT05564819 | Completed Phase 1 DMC

• 1 other identifier: NCH202207156
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesic; Enhanced Recovery After Surgery; Postoperative Pain; Infant ALL; Acetaminophen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• liver function

  48 hours after surgery

• renal function

  48 hours after surgery

• LOS

  30 days after surgery

• Using CRIES scale to assess the pain level at 1 hour after postoperative awakening

  1 hour after postoperative awakening

• Using CRIES scale to assess the pain level at 6 hours after postoperative awakening

  6 hours after postoperative awakening

Study Arms (2)

Treatment group

EXPERIMENTAL

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

placebo group

PLACEBO COMPARATOR

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

Drug: Sterilized water

Interventions

Acetaminophen DRUG

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.

Treatment group

Sterilized water DRUG

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.

placebo group

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Nanjing Children's Hospital: lead

Study Sites (1)

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of neonatal surgery

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 4, 2022
• Study Start: September 14, 2022
• Primary Completion: May 15, 2023
• Study Completion: July 31, 2023
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)