Acetaminophen Before Surgery Lowers Postop Pain in Pediatric Solid Tumor Patients (ERAS)

NCT07095816 | Completed Phase 1 DMC

• 1 other identifier: NCH202305012-1
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is the predominant subjective symptom experienced during the perioperative period in pediatric patients with solid tumors. Intense pain may impede early postoperative activities and delay the recovery process. Preemptive analgesia，as a component of multimodal analgesia strategies，aims to mitigate pain by administering analgesic interventions prior to the application of a noxious stimulus. This approach seeks to diminish both peripheral and central sensitization to pain，thereby alleviating postoperative pain. Currently，while preoperative acetaminophen is widely used in adult surgeries，research is limited for its use in pediatrics. This study aims to evaluate the impact of preemptive acetaminophen on reducing postoperative pain in children with solid tumors under the mode of ERAS.

Conditions

Analgesic; Enhanced Recovery After Surgery; Postoperative Pain; Acetaminophen; Tumor

Outcome Measures

Primary Outcomes (12)

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

  The FLACC (Face, Legs, Activity, Cry, Consolability) scale score was assessed 1 hour after children aged 1 month to 6 years woke up. It evaluates five items: facial expression, leg movement, activity, crying, and consolability, each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating greater pain: 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  1 hour after postoperative awakening

• Using FLACC scale to assess the pain level at 3 hours after postoperative awakening

  The FLACC (Face, Legs, Activity, Cry, Consolability) scale score was assessed 3 hours after children aged 1 month to 6 years woke up. It evaluates five items: facial expression, leg movement, activity, crying, and consolability, each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating greater pain: 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  3 hours after postoperative awakening

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

  The FLACC (Face, Legs, Activity, Cry, Consolability) scale score was assessed 6 hours after children aged 1 month to 6 years woke up. It evaluates five items: facial expression, leg movement, activity, crying, and consolability, each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating greater pain: 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  6 hours after postoperative awakening

• Using FLACC scale to assess the pain level at 12 hours after postoperative awakening

  The FLACC (Face, Legs, Activity, Cry, Consolability) scale score was assessed 12 hours after children aged 1 month to 6 years woke up. It evaluates five items: facial expression, leg movement, activity, crying, and consolability, each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating greater pain: 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  12 hours after postoperative awakening

• Using FLACC scale to assess the pain level at 24 hours after postoperative awakening

  The FLACC (Face, Legs, Activity, Cry, Consolability) scale score was assessed 24 hours after children aged 1 month to 6 years woke up. It evaluates five items: facial expression, leg movement, activity, crying, and consolability, each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating greater pain: 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  24 hours after postoperative awakening

• Using FLACC scale to assess the pain level at 48 hours after postoperative awakening

  The FLACC (Face, Legs, Activity, Cry, Consolability) scale score was assessed 48 hours after children aged 1 month to 6 years woke up. It evaluates five items: facial expression, leg movement, activity, crying, and consolability, each scored from 0 to 2. Total scores range from 0 to 10, with higher scores indicating greater pain: 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  48 hours after postoperative awakening

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

  The NRS (Numerical Rating Scale) pain score was assessed 1 hour after children aged 6 years and above woke up. Total scores range from 0 (no pain) to 10 (most severe pain). Scores are categorized as 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  1 hour after postoperative awakening

• Using NRS scale to assess the pain level at 3 hours after postoperative awakening

  The NRS (Numerical Rating Scale) pain score was assessed 3 hours after children aged 6 years and above woke up. Total scores range from 0 (no pain) to 10 (most severe pain). Scores are categorized as 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  3 hours after postoperative awakening

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

  The NRS (Numerical Rating Scale) pain score was assessed 6 hours after children aged 6 years and above woke up. Total scores range from 0 (no pain) to 10 (most severe pain). Scores are categorized as 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  6 hours after postoperative awakening

• Using NRS scale to assess the pain level at 12 hours after postoperative awakening

  The NRS (Numerical Rating Scale) pain score was assessed 12 hours after children aged 6 years and above woke up. Total scores range from 0 (no pain) to 10 (most severe pain). Scores are categorized as 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  12 hours after postoperative awakening

• Using NRS scale to assess the pain level at 24 hours after postoperative awakening

  The NRS (Numerical Rating Scale) pain score was assessed 24 hours after children aged 6 years and above woke up. Total scores range from 0 (no pain) to 10 (most severe pain). Scores are categorized as 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  24 hours after postoperative awakening

• Using NRS scale to assess the pain level at 48 hours after postoperative awakening

  The NRS (Numerical Rating Scale) pain score was assessed 48 hours after children aged 6 years and above woke up. Total scores range from 0 (no pain) to 10 (most severe pain). Scores are categorized as 1-3 for mild, 4-6 for moderate, and 7-10 for severe pain.

  48 hours after postoperative awakening

Secondary Outcomes (15)

• The number of patient-controlled analgesia (PCA) pump activations

  during the first 48 postoperative hours

• Serum Alanine Aminotransferase (ALT) Concentration

  24 hours after surgery

• Serum Aspartate Aminotransferase (AST) Concentration

  24 hours after surgery

• Serum Urea Concentration

  24 hours after surgery

• Plasma Creatinine Concentration

  24 hours after surgery

Study Arms (2)

Acetaminophen（APAP）

EXPERIMENTAL

The experimental group received oral acetaminophen（10 mg/kg）two hours prior to surgery.

Drug: Acetaminophen

sterilized water

PLACEBO COMPARATOR

The placebo group received 10 mg/kg sterilized water two hours prior to surgery.

Drug: Sterilized water

Interventions

Acetaminophen DRUG

A prospective randomized controlled trial was conducted involving pediatric patients with solid tumors. Participants who met the inclusion criteria were randomly assigned using a computer-generated random number table. The APAP group was administered acetaminophen orally at a dose of 10 mg/kg body weight 2 hours before the surgical procedure.

Acetaminophen（APAP）

Sterilized water DRUG

The placebo group was administered 10 mg/kg of sterile water orally two hours before the surgical procedure.

sterilized water

Eligibility Criteria

• Age: 1 Month - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed Consent: Written informed consent was obtained from the parents or legal guardians of all pediatric participants.
• Age Requirement: Patients aged \>1 month (infants and children) were eligible for enrollment.
• Diagnosis \& Treatment:
• Radiologically or pathologically confirmed solid tumors. Ⅱ.Scheduled to undergo tumor resection surgery in the Department of Pediatric Surgical Oncology, Children's Hospital Affiliated to Nanjing Medical University.

You may not qualify if:

• Lack of Informed Consent: Parental/guardian informed consent was not obtained. ②Allergy/Intolerance: Known hypersensitivity or contraindication to acetaminophen (paracetamol).
• Hepatic Impairment:Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \>3× the upper limit of normal (ULN).
• Renal Dysfunction:Serum urea or creatinine levels exceeding the ULN. ⑤Recent Analgesic Use: Administration of any analgesic medication within 12 hours preoperatively.

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; Neoplasms

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 Officials

• Weibing Tang

  Children's Hospital of Nanjing Medical University

  STUDY CHAIR

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: July 13, 2025
• First Posted: July 31, 2025
• Study Start: May 15, 2023
• Primary Completion: February 27, 2025
• Study Completion: March 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become accessible:Starting Date: 6 months after study completion；End Date: Minimum 5 years after publication
• Access Criteria: Access to IPD requires submitting a formal research proposal (including hypothesis/analysis plan, ethical approval proof if applicable, and conflict of interest disclosure) to the investigator's email, along with a signed Data Use Agreement (DUA) prohibiting re-identification, commercial use, and redistribution.

Locations

CN (1)