Clinical trial NCT05564819: Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants
Official title: Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Under Enhanced Recovery After Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Analgesic
Enhanced Recovery After Surgery
Postoperative Pain
Infant ALL
Acetaminophen
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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);

Primary outcomes:
measure: Using CRIES scale to assess the pain level at 12 hours after postoperative awakening
timeFrame: 12 hours after postoperative awakening
Secondary outcomes:
measure: liver function
timeFrame: 48 hours after surgery
measure: renal function
timeFrame: 48 hours after surgery
measure: LOS
timeFrame: 30 days after surgery
measure: Using CRIES scale to assess the pain level at 1 hour after postoperative awakening
timeFrame: 1 hour after postoperative awakening
measure: Using CRIES scale to assess the pain level at 6 hours after postoperative awakening
timeFrame: 6 hours after postoperative awakening
measure: Using CRIES scale to assess the pain level at 18 hours after postoperative awakening
timeFrame: 18 hours after postoperative awakening
measure: Using CRIES scale to assess the pain level at 24 hours after postoperative awakening
timeFrame: 24 hours after postoperative awakening
measure: Using CRIES scale to assess the pain level at 36 hours after postoperative awakening
timeFrame: 36 hours after postoperative awakening
measure: Using CRIES scale to assess the pain level at 48 hours after postoperative awakening
timeFrame: 48 hours after postoperative awakening
measure: Using FLACC scale to assess the pain level at 1 hour after postoperative awakening
timeFrame: 1 hour after postoperative awakening
measure: Using FLACC scale to assess the pain level at 6 hours after postoperative awakening
timeFrame: 6 hours after postoperative awakening
measure: Using FLACC scale to assess the pain level at 12 hours after postoperative awakening
timeFrame: 12 hours after postoperative awakening
measure: Using FLACC scale to assess the pain level at 18 hours after postoperative awakening
timeFrame: 18 hours after postoperative awakening
measure: Using FLACC scale to assess the pain level at 24 hours after postoperative awakening
timeFrame: 24 hours after postoperative awakening
measure: Using FLACC scale to assess the pain level at 36 hours after postoperative awakening
timeFrame: 36 hours after postoperative awakening
measure: Using FLACC scale to assess the pain level at 48 hours after postoperative awakening
timeFrame: 48 hours after postoperative awakening
measure: Using CHIPPS scale to assess the pain level at 1 hour after postoperative awakening
timeFrame: 1 hour after postoperative awakening
measure: Using CHIPPS scale to assess the pain level at 6 hours after postoperative awakening
timeFrame: 6 hours after postoperative awakening
measure: Using CHIPPS scale to assess the pain level at 12 hours after postoperative awakening
timeFrame: 12 hours after postoperative awakening
measure: Using CHIPPS scale to assess the pain level at 18 hours after postoperative awakening
timeFrame: 18 hours after postoperative awakening
measure: Using CHIPPS scale to assess the pain level at 24 hours after postoperative awakening
timeFrame: 24 hours after postoperative awakening
measure: Using CHIPPS scale to assess the pain level at 36 hours after postoperative awakening
timeFrame: 36 hours after postoperative awakening
measure: Using CHIPPS scale to assess the pain level at 48 hours after postoperative awakening
timeFrame: 48 hours after postoperative awakening
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: