NCT05564819

Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Nanjing Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Analgesic
• Enhanced Recovery After Surgery
• Postoperative Pain
• Infant ALL
• Acetaminophen

Interventions

Type	Name	Description
DRUG	Acetaminophen	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.
DRUG	Sterilized water	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.

Timeline

• Start date: 2022-09-14
• Primary completion: 2023-05-15
• Completion: 2023-07-31
• First posted: 2022-10-04
• Last updated: 2024-07-10

Locations

1 site across 1 country: China