CompletedPhase 1

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

China182 participantsStarted 2023-05-15

Plain-language 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.

Who can participate

Age range

1 Month – 15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 hour after postoperative awakening

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

Timeframe: 3 hours after postoperative awakening

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

Timeframe: 6 hours after postoperative awakening

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

Timeframe: 12 hours after postoperative awakening

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

Timeframe: 24 hours after postoperative awakening

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

Timeframe: 48 hours after postoperative awakening

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

Trial details

NCT IDNCT07095816

SponsorNanjing Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-27

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