A Phase 1 interventional study of Acetaminophen and Sterilized water in Analgesic, Enhanced Recovery After Surgery and Postoperative Pain, sponsored by Nanjing Children's Hospital. Completed at 1 site in China. Open to participants aged 1 Month to 15 Years. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Nanjing Children's Hospital · Phase 1, Interventional, and Treatment
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.
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.
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:
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.
The experimental group received oral acetaminophen（10 mg/kg）two hours prior to surgery.
Drug: Acetaminophen
The placebo group received 10 mg/kg sterilized water two hours prior to surgery.
Drug: Sterilized water
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.
The placebo group was administered 10 mg/kg of sterile water orally two hours before the surgical procedure.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 hours after postoperative awakening
The number of patient-controlled analgesia (PCA) pump activations
The number of patient-controlled analgesia (PCA) pump activations within 48 hours postoperatively
Time frame: during the first 48 postoperative hours
Serum Alanine Aminotransferase (ALT) Concentration
alanine aminotransferase
Time frame: 24 hours after surgery
Serum Aspartate Aminotransferase (AST) Concentration
aspartate aminotransferase
Time frame: 24 hours after surgery
Serum Urea Concentration
urea
Time frame: 24 hours after surgery
Plasma Creatinine Concentration
creatinine values
Time frame: 24 hours after surgery
Serum Procalcitonin Concentration (ng/mL)
Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.
Time frame: 24 hours after surgery
Serum C-Reactive Protein Concentration (mg/L)
Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.
Time frame: 24 hours after surgery
Peripheral White Blood Cell Count (×10⁹/L)
Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.
Time frame: 24 hours after surgery
Absolute Neutrophil Count (×10⁹/L)
Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.
Time frame: 24 hours after surgery
Absolute Lymphocyte Count (×10⁹/L)
Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.
Time frame: 24 hours after surgery
Neutrophil-to-Lymphocyte Ratio
Postoperative inflammatory markers including procalcitonin, C-reactive protein, white blood cell count, absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio.
Time frame: 24 hours after surgery
Intraoperative Respiratory Rate (breaths per minute)
Intraoperative monitoring of respiratory rate, heart rate, systolic blood pressure, and diastolic blood pressure was performed in pediatric patients throughout the surgical procedure.
Time frame: during the operation
Intraoperative Heart Rate (beats per minute)
Intraoperative monitoring of respiratory rate, heart rate, systolic blood pressure, and diastolic blood pressure was performed in pediatric patients throughout the surgical procedure.
Time frame: during the operation
Intraoperative Systolic Blood Pressure (mmHg)
Intraoperative monitoring of respiratory rate, heart rate, systolic blood pressure, and diastolic blood pressure was performed in pediatric patients throughout the surgical procedure.
Time frame: during the operation
Intraoperative Diastolic Blood Pressure (mmHg)
Intraoperative monitoring of respiratory rate, heart rate, systolic blood pressure, and diastolic blood pressure was performed in pediatric patients throughout the surgical procedure.
Time frame: during the operation
Plan to share: Yes — De-identified individual participant data (including demographic, clinical, and outcome variables) collected during the trial will be made available to qualified researchers.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Nanjing Children's Hospital