Clinical trial · Interventional
Acetaminophen Before Surgery Lowers Postop Pain in Pediatric Solid Tumor Patients (ERAS)
Administering Acetaminophen Orally Before Surgery Reduces Postoperative Pain in Children With Solid Tumors Under the Mode of ERAS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acetaminophen | — | UNRESOLVED | — |
| Analgesic | — | UNRESOLVED | — |
| Enhanced Recovery After Surgery | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Sterilized water | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acetaminophen（APAP）
- description
- The experimental group received oral acetaminophen（10 mg/kg）two hours prior to surgery.
- interventionNames
- Drug: Acetaminophen
- type
- PLACEBO_COMPARATOR
- label
- sterilized water
- description
- The placebo group received 10 mg/kg sterilized water two hours prior to surgery.
- interventionNames
- Drug: Sterilized water
Primary outcomes (12)
- measure
- Using FLACC scale to assess the pain level at 1 hour after postoperative awakening
- timeFrame
- 1 hour after postoperative awakening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 15 Years
Show eligibility criteria text
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).References
Publications (0)
Data not yet available