Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

Nanjing Children's Hospital

Status and phase: Completed; Phase 1

Conditions: Infant ALL; Postoperative Pain; Analgesic; Acetaminophen; Enhanced Recovery After Surgery

Treatments: Drug: Sterilized water; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT05564819

NCH202207156

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

After recovering and returning to the ward, acetaminophen (10mg/kg) was taken orally immediately; once every 6 hours, a total of 4 times.

Treatment:

Drug: Acetaminophen

placebo group

Placebo Comparator group

Description:

The same amount of sterilized water was administered orally at the same time points.

Treatment:

Drug: Sterilized water