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NCT Number: NCT07095816

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

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.

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Key information

Conditions

Analgesic Acetaminophen Enhanced Recovery After Surgery Neoplasms Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Tumor

Age range

1 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210008, China

About this study

Pediatric oncology patients face unique challenges due to their distinct clinical profile. Solid tumors like neuroblastomas, teratomas, and rhabdomyosarcomas often develop in complex areas such as the retroperitoneum, pelvis, or mediastinum, where they grow invasively and can encase major blood vessels. Children typically have larger tumor-to-body size ratios than adults, necessitating more extensive surgeries and resulting in larger wounds from tumor and lymph node removal. Their poor preoperative nutrition and compromised healing abilities, due to both their disease and treatments, lead to slower wound healing and higher risk of complications.

Managing pain in pediatric cancer patients is challenging. Almost all experience pain, with over 70% facing severe pain, making it their most distressing symptom. Young children's limited cognitive abilities often lead to underreported and undertreated pain, especially after surgery. This unrelieved pain can impair breathing, hinder movement, increase infection risk, and worsen wasting. Most concerning are the potential long-term neurological effects, as significant pain in childhood may lead to lasting changes in brain structure and function.

A comprehensive meta-analysis highlights several effective preemptive analgesics, including lornoxicam, pregabalin, ibuprofen, gabapentin, and acetaminophen (APAP). APAP is particularly popular in pediatrics for its safety when properly dosed. It is quickly absorbed in the gut and metabolized in the liver, primarily by cytochrome P450 enzymes, producing a toxic intermediate, NAPQI, which is detoxified by glutathione. APAP's analgesic effects involve peripheral COX inhibition and central modulation of COX, serotonin, L-arginine/NO, endocannabinoid, and redox pathways. Preoperative APAP can prevent pain sensitization by blocking nociceptive signal transmission to the central nervous system.

APAP has proven effective for preemptive analgesia in pediatric surgeries like tonsillectomy and appendectomy, reducing pain and enhancing recovery. However, its role in pediatric oncologic surgery is unstudied, highlighting a need to explore its use in ERAS protocols for pain management in tumor resections. This study seeks to fill that gap, potentially improving perioperative pain care for these patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • PCA Exclusion: Patients not receiving postoperative intravenous patient-controlled analgesia (PCA).

Treatment and study plan

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.

Sterilized water

Drug

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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. Using FLACC scale to assess the pain level at 6 hours after postoperative awakening

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: during the first 48 postoperative hours

    The number of patient-controlled analgesia (PCA) pump activations within 48 hours postoperatively

  2. Serum Alanine Aminotransferase (ALT) Concentration

    Time frame: 24 hours after surgery

    alanine aminotransferase

  3. Serum Aspartate Aminotransferase (AST) Concentration

    Time frame: 24 hours after surgery

    aspartate aminotransferase

  4. Serum Urea Concentration

    Time frame: 24 hours after surgery

    urea

  5. Plasma Creatinine Concentration

    Time frame: 24 hours after surgery

    creatinine values

  6. Serum Procalcitonin Concentration (ng/mL)

    Time frame: 24 hours after surgery

    Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.

  7. Serum C-Reactive Protein Concentration (mg/L)

    Time frame: 24 hours after surgery

    Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.

  8. Peripheral White Blood Cell Count (×10⁹/L)

    Time frame: 24 hours after surgery

    Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.

  9. Absolute Neutrophil Count (×10⁹/L)

    Time frame: 24 hours after surgery

    Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.

  10. Absolute Lymphocyte Count (×10⁹/L)

    Time frame: 24 hours after surgery

    Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.

  11. Neutrophil-to-Lymphocyte Ratio

    Time frame: 24 hours after surgery

    Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.

  12. Intraoperative Respiratory Rate (breaths per minute)

    Time frame: during the operation

    Intraoperative monitoring of respiratory rate, heart rate, systolic blood pressure, and diastolic blood pressure was performed in pediatric patients throughout the surgical procedure.

  13. Intraoperative Heart Rate (beats per minute)

    Time frame: during the operation

    Intraoperative monitoring of respiratory rate, heart rate, systolic blood pressure, and diastolic blood pressure was performed in pediatric patients throughout the surgical procedure.

  14. Intraoperative Systolic Blood Pressure (mmHg)

    Time frame: during the operation

    Intraoperative monitoring of respiratory rate, heart rate, systolic blood pressure, and diastolic blood pressure was performed in pediatric patients throughout the surgical procedure.

  15. Intraoperative Diastolic Blood Pressure (mmHg)

    Time frame: during the operation

    Intraoperative monitoring of respiratory rate, heart rate, systolic blood pressure, and diastolic blood pressure was performed in pediatric patients throughout the surgical procedure.

Sponsors and collaborators

Lead sponsor

Nanjing Children's Hospital

Other

Registry information

Official study title

Administering Acetaminophen Orally Before Surgery Reduces Postoperative Pain in Children With Solid Tumors Under the Mode of ERAS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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