Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Under Enhanced Recovery After Surgery

Conditions
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Analgesic, Enhanced Recovery After Surgery, Postoperative Pain, Infant ALL, Acetaminophen

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Sterilized water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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);

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>After recovering and returning to the ward, acetaminophen (10mg/kg) was taken orally immediately; once every 6 hours, a total of 4 times. | Drug: Acetaminophen<br>* 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.<br>|
| Placebo Comparator: placebo group<br>The same amount of sterilized water was administered orally at the same time points. | Drug: Sterilized water<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 hours after postoperative awakening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver function | alanine aminotransferase, aspartate aminotransferase | 48 hours after surgery | 
| renal function | urea and creatinine values | 48 hours after surgery | 
| LOS | Length of stay after surgery | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 48 hours after postoperative awakening |