Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564819
• Other study ID #: NCH202207156
• Status: Recruiting
• Phase: Phase 1
• Start date: September 14, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Nanjing Children's Hospital
• Contact: Jie Tang
• Phone: +86 18262637795
• Email: jietang1123[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 12 Months

Eligibility

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);

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	liver function	alanine aminotransferase, aspartate aminotransferase	48 hours after surgery
Secondary	renal function	urea and creatinine values	48 hours after surgery
Secondary	LOS	Length of stay after surgery	30 days after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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