AnalgesicPhase 1NCT05564819
Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants
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 will bring early and long-term adverse reactions to infants. The investigators need to pay attention to whether there is pain in infants after surgery. Since infants cannot self-report pain,The investigators need to use appropriate pain assessment scale to evaluate the pain of these infants, so as to understand… Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- 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
- 220 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2022to 31 Jul 2023
- 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 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent was obtained from parents of children;
- Infants aged 0-12 months;
- Children who underwent abdominal and perineal surgery in the Department of Neonatal Surgery, Children's Hospital Affiliated to Nanjing Medical University and returned to the unaccompanied ward after removal of tracheal intubation.
Who cannot join
- No informed consent was obtained from parents;
- known allergy or intolerance to acetaminophen;
- Children with liver function impairment (alanine aminotransferase/aspartate aminotransferase (ALAT/ASAT) more than three times the reference value;
- Children with renal insufficiency (urea and creatinine values exceeding the upper limit of reference values);
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: Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Under Enhanced Recovery After Surgery
Pain will bring early and long-term adverse reactions to infants. The investigators need to pay attention to whether there is pain in infants after surgery. Since infants cannot self-report pain,The investigators need to use appropriate pain assessment scale to evaluate the pain of these infants, so as to understand the status of postoperative pain in children. The result of pain score not only enables investigators to understand the pain status of children, but also helps investigators to give corresponding intervention and treatment according to the pain degree of children. Postoperative pain management is one of the core contents of ERAS. Effective pain management is beneficial to the early postoperative recovery of infants and reduces the adverse reactions caused by pain. Sveral studies have confirmed that the combination of acetaminophen and opioids could reduce the use of opioids after surgery. But even if opioid use is reduced, it still causes many side effects for children. This study evaluated the safety and efficacy of acetaminophen alone for postoperative analgesia in infants.
- Being tested
- Acetaminophen, Sterilized water
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
When the infants woke up after surgery and were transported back to the ward, they were randomly divided into two groups immediately. The intervention group was given oral acetaminophen, once every 6 hours, for a total of 4 times.
Sterilized waterDrug
When the infants woke up after surgery and were transported back to the ward, they were randomly divided into two groups immediately. The control group was given sterilized water, once every 6 hours, for a total of 4 times.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | After recovering and returning to the ward, acetaminophen (10mg/kg) was taken orally immediately; once every 6 hours, a total of 4 times. Receives: Drug: Acetaminophen |
| placebo group | Placebo comparator | The same amount of sterilized water was administered orally at the same time points. Receives: Drug: Sterilized water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using CRIES scale to assess the pain level at 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up
Measured: 12 hours after postoperative awakening
Secondary outcomes (23)
liver function
alanine aminotransferase, aspartate aminotransferase
Measured: 48 hours after surgery
renal function
urea and creatinine values
Measured: 48 hours after surgery
LOS
Length of stay after surgery
Measured: 30 days after surgery
Using CRIES scale to assess the pain level at 1 hour after postoperative awakening
The pain score was evaluated 1 hour after Children wake up
Measured: 1 hour after postoperative awakening
Using CRIES scale to assess the pain level at 6 hours after postoperative awakening
The pain score was evaluated 6 hours after Children wake up
Measured: 6 hours after postoperative awakening
Using CRIES scale to assess the pain level at 18 hours after postoperative awakening
The pain score was evaluated 18 hours after Children wake up
Measured: 18 hours after postoperative awakening
Using CRIES scale to assess the pain level at 24 hours after postoperative awakening
The pain score was evaluated 24 hours after Children wake up
Measured: 24 hours after postoperative awakening
Using CRIES scale to assess the pain level at 36 hours after postoperative awakening
The pain score was evaluated 36 hours after Children wake up
Measured: 36 hours after postoperative awakening
Using CRIES scale to assess the pain level at 48 hours after postoperative awakening
The pain score was evaluated 48 hours after Children wake up
Measured: 48 hours after postoperative awakening
Using FLACC scale to assess the pain level at 1 hour after postoperative awakening
The pain score was evaluated 1 hour after Children wake up
Measured: 1 hour after postoperative awakening
Using FLACC scale to assess the pain level at 6 hours after postoperative awakening
The pain score was evaluated 6 hours after Children wake up
Measured: 6 hours after postoperative awakening
Using FLACC scale to assess the pain level at 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up
Measured: 12 hours after postoperative awakening
Using FLACC scale to assess the pain level at 18 hours after postoperative awakening
The pain score was evaluated 18 hours after Children wake up
Measured: 18 hours after postoperative awakening
Using FLACC scale to assess the pain level at 24 hours after postoperative awakening
The pain score was evaluated 24 hours after Children wake up
Measured: 24 hours after postoperative awakening
Using FLACC scale to assess the pain level at 36 hours after postoperative awakening
The pain score was evaluated 36 hours after Children wake up
Measured: 36 hours after postoperative awakening
Using FLACC scale to assess the pain level at 48 hours after postoperative awakening
The pain score was evaluated 48 hours after Children wake up
Measured: 48 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 1 hour after postoperative awakening
The pain score was evaluated 1 hour after Children wake up
Measured: 1 hour after postoperative awakening
Using CHIPPS scale to assess the pain level at 6 hours after postoperative awakening
The pain score was evaluated 6 hours after Children wake up
Measured: 6 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up
Measured: 12 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 18 hours after postoperative awakening
The pain score was evaluated 18 hours after Children wake up
Measured: 18 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 24 hours after postoperative awakening
The pain score was evaluated 24 hours after Children wake up
Measured: 24 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 36 hours after postoperative awakening
The pain score was evaluated 36 hours after Children wake up
Measured: 36 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 48 hours after postoperative awakening
The pain score was evaluated 48 hours after Children wake up
Measured: 48 hours after postoperative awakening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start14 Sep 2022
- Primary completion15 May 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 220 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564819
- Sponsor's protocol ID
- NCH202207156
- Status last verified
- Jul 2024
- First submitted
- 16 Sep 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Shi C, Tang J, Sun W, Li W, Lv X, Tang W. Efficacy and safety of oral paracetamol for the management of acute postoperative pain in neonates and infants: a randomized clinical trial. World J Pediatr Surg. 2026 Feb 3;9(1):e001131. doi: 10.1136/wjps-2025-001131. eCollection 2026.
PubMed 41657425
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Under Enhanced Recovery After Surgery
- ClinicalTrials.gov ID
- NCT05564819
- Acronym / sponsor ID
- NCH202207156
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 4 Oct 2022 (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 will bring early and long-term adverse reactions to infants. The investigators need to pay attention to whether there is pain in infants after surgery. Since infants cannot self-report pain,The investigators need to use appropriate pain assessment scale to evaluate the pain of these infants, so as to understand the status of postoperative pain in children. The result of pain score not only enables investigators to understand the pain status of children, but also helps investigators to give corresponding intervention and treatment according to the pain degree of children. Postoperative pain management is one of the core contents of ERAS. Effective pain management is beneficial to the early postoperative recovery of infants and reduces the adverse reactions caused by pain. Sveral studies have confirmed that the combination of acetaminophen and opioids could reduce the use of opioids after surgery. But even if opioid use is reduced, it still causes many side effects for children. This study evaluated the safety and efficacy of acetaminophen alone for postoperative analgesia in infants.
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 |
|---|---|---|
| Treatment group | Experimental | Drug: AcetaminophenAfter recovering and returning to the ward, acetaminophen (10mg/kg) was taken orally immediately; once every 6 hours, a total of 4 times. |
| placebo group | Placebo comparator | Drug: Sterilized waterThe same amount of sterilized water was administered orally at the same time points. |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Informed consent was obtained from parents of children;
- Infants aged 0-12 months;
- Children who underwent abdominal and perineal surgery in the Department of Neonatal Surgery, Children's Hospital Affiliated to Nanjing Medical University and returned to the unaccompanied ward after removal of tracheal intubation.
Key exclusion criteria (4 listed)
- No informed consent was obtained from parents;
- known allergy or intolerance to acetaminophen;
- Children with liver function impairment (alanine aminotransferase/aspartate aminotransferase (ALAT/ASAT) more than three times the reference value;
- Children with renal insufficiency (urea and creatinine values exceeding the upper limit of reference values);
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 |
|---|---|---|
| AcetaminophenWhen the infants woke up after surgery and were transported back to the ward, they were randomly divided into two groups immediately. The intervention group was given oral acetaminophen, once every 6 hours, for a total of 4 times. | Drug | Treatment group |
| Sterilized waterWhen the infants woke up after surgery and were transported back to the ward, they were randomly divided into two groups immediately. The control group was given sterilized water, once every 6 hours, for a total of 4 times. | Drug | placebo group |
Primary outcome
Using CRIES scale to assess the pain level at 12 hours after postoperative awakening
Time frame: 12 hours after postoperative awakening
The pain score was evaluated 12 hours after Children wake up
23 secondary outcomes
liver function
Time frame: 48 hours after surgery
renal function
Time frame: 48 hours after surgery
LOS
Time frame: 30 days after surgery
Using CRIES scale to assess the pain level at 1 hour after postoperative awakening
Time frame: 1 hour after postoperative awakening
Using CRIES scale to assess the pain level at 6 hours after postoperative awakening
Time frame: 6 hours after postoperative awakening
Using CRIES scale to assess the pain level at 18 hours after postoperative awakening
Time frame: 18 hours after postoperative awakening
Using CRIES scale to assess the pain level at 24 hours after postoperative awakening
Time frame: 24 hours after postoperative awakening
Using CRIES scale to assess the pain level at 36 hours after postoperative awakening
Time frame: 36 hours after postoperative awakening
Using CRIES scale to assess the pain level at 48 hours after postoperative awakening
Time frame: 48 hours after postoperative awakening
Using FLACC scale to assess the pain level at 1 hour after postoperative awakening
Time frame: 1 hour after postoperative awakening
Using FLACC scale to assess the pain level at 6 hours after postoperative awakening
Time frame: 6 hours after postoperative awakening
Using FLACC scale to assess the pain level at 12 hours after postoperative awakening
Time frame: 12 hours after postoperative awakening
Using FLACC scale to assess the pain level at 18 hours after postoperative awakening
Time frame: 18 hours after postoperative awakening
Using FLACC scale to assess the pain level at 24 hours after postoperative awakening
Time frame: 24 hours after postoperative awakening
Using FLACC scale to assess the pain level at 36 hours after postoperative awakening
Time frame: 36 hours after postoperative awakening
Using FLACC scale to assess the pain level at 48 hours after postoperative awakening
Time frame: 48 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 1 hour after postoperative awakening
Time frame: 1 hour after postoperative awakening
Using CHIPPS scale to assess the pain level at 6 hours after postoperative awakening
Time frame: 6 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 12 hours after postoperative awakening
Time frame: 12 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 18 hours after postoperative awakening
Time frame: 18 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 24 hours after postoperative awakening
Time frame: 24 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 36 hours after postoperative awakening
Time frame: 36 hours after postoperative awakening
Using CHIPPS scale to assess the pain level at 48 hours after postoperative awakening
Time frame: 48 hours after postoperative awakening
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 10 Jul 2024.
- Derived from this study: PubMed 41657425Shi C, Tang J, Sun W, Li W, Lv X, Tang W. Efficacy and safety of oral paracetamol for the management of acute postoperative pain in neonates and infants: a randomized clinical trial. World J Pediatr Surg. 2026 Feb 3;9(1):e001131. doi: 10.1136/wjps-2025-001131. eCollection 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 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 10 Jul 2024. 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 CRIES scale to assess the pain level at 12 hours after postoperative awakening (time frame: 12 hours after postoperative awakening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05564819, which also lists 1 linked publication.
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 10 Jul 2024.