AnalgesicPhase 1NCT07095816
Acetaminophen Before Surgery Lowers Postop Pain in Pediatric Solid Tumor Patients (ERAS)
A Phase 1 study testing Acetaminophen and Sterilized water in people with Analgesic and Enhanced Recovery After Surgery, run by Nanjing Children's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 15 years
- Conditions the study is for
- Analgesic, Enhanced Recovery After Surgery, Postoperative Pain
- What is being tested?
- Acetaminophen and Sterilized water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 30 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210008
About this study
Official title: Administering Acetaminophen Orally Before Surgery Reduces Postoperative Pain in Children With Solid Tumors Under the Mode of 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.
Read the detailed description
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.
- Being tested
- Acetaminophen, Sterilized water
- Medical subject headings
- Pain, Postoperative, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
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 waterDrug
The placebo group was administered 10 mg/kg of sterile water orally two hours before the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen（APAP） | Experimental | The experimental group received oral acetaminophen（10 mg/kg）two hours prior to surgery. Receives: Drug: Acetaminophen |
| sterilized water | Placebo comparator | The placebo group received 10 mg/kg sterilized water two hours prior to surgery. Receives: Drug: Sterilized water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48 hours after postoperative awakening
Secondary outcomes (15)
The number of patient-controlled analgesia (PCA) pump activations
The number of patient-controlled analgesia (PCA) pump activations within 48 hours postoperatively
Measured: during the first 48 postoperative hours
Serum Alanine Aminotransferase (ALT) Concentration
alanine aminotransferase
Measured: 24 hours after surgery
Serum Aspartate Aminotransferase (AST) Concentration
aspartate aminotransferase
Measured: 24 hours after surgery
Serum Urea Concentration
urea
Measured: 24 hours after surgery
Plasma Creatinine Concentration
creatinine values
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start15 May 2023
- Primary completion27 Feb 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibing Tang, Nanjing Children's Hospital
- Investigators
- Weibing Tang, Study chair, Children's Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095816
- Sponsor's protocol ID
- NCH202305012-1
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including demographic, clinical, and outcome variables) collected during the trial will be made available to qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administering Acetaminophen Orally Before Surgery Reduces Postoperative Pain in Children With Solid Tumors Under the Mode of ERAS
- ClinicalTrials.gov ID
- NCT07095816
- Acronym / sponsor ID
- NCH202305012-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen（APAP） | Experimental | Drug: AcetaminophenThe experimental group received oral acetaminophen（10 mg/kg）two hours prior to surgery. |
| sterilized water | Placebo comparator | Drug: Sterilized waterThe placebo group received 10 mg/kg sterilized water two hours prior to surgery. |
Who may qualify
- Ages
- 1 month to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Informed Consent: Written informed consent was obtained from the parents or legal guardians of all pediatric participants.
Key exclusion criteria (4 listed)
- Lack of Informed Consent: Parental/guardian informed consent was not obtained. ②Allergy/Intolerance: Known hypersensitivity or contraindication to acetaminophen (paracetamol).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenA 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. | Drug | Acetaminophen（APAP） |
| Sterilized waterThe placebo group was administered 10 mg/kg of sterile water orally two hours before the surgical procedure. | Drug | sterilized water |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
15 secondary outcomes
The number of patient-controlled analgesia (PCA) pump activations
Time frame: during the first 48 postoperative hours
Serum Alanine Aminotransferase (ALT) Concentration
Time frame: 24 hours after surgery
Serum Aspartate Aminotransferase (AST) Concentration
Time frame: 24 hours after surgery
Serum Urea Concentration
Time frame: 24 hours after surgery
Plasma Creatinine Concentration
Time frame: 24 hours after surgery
Serum Procalcitonin Concentration (ng/mL)
Time frame: 24 hours after surgery
Serum C-Reactive Protein Concentration (mg/L)
Time frame: 24 hours after surgery
Peripheral White Blood Cell Count (×10⁹/L)
Time frame: 24 hours after surgery
Absolute Neutrophil Count (×10⁹/L)
Time frame: 24 hours after surgery
Absolute Lymphocyte Count (×10⁹/L)
Time frame: 24 hours after surgery
Neutrophil-to-Lymphocyte Ratio
Time frame: 24 hours after surgery
Intraoperative Respiratory Rate (breaths per minute)
Time frame: during the operation
Intraoperative Heart Rate (beats per minute)
Time frame: during the operation
Intraoperative Systolic Blood Pressure (mmHg)
Time frame: during the operation
Intraoperative Diastolic Blood Pressure (mmHg)
Time frame: during the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including demographic, clinical, and outcome variables) collected during the trial will be made available to qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weibing Tang study chair
Children's Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acetaminophen and Sterilized water in people with Analgesic and Enhanced Recovery After Surgery, run by Nanjing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using FLACC scale to assess the pain level at 1 hour after postoperative awakening (time frame: 1 hour after postoperative awakening). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.