Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

Sponsor
Nanjing Children's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05564819
Collaborator
(none)
220
1
2
15.5
14.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
220 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Under Enhanced Recovery After Surgery
Actual Study Start Date :
Sep 14, 2022
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

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
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.

Placebo Comparator: placebo group

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

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.

Outcome Measures

Primary Outcome Measures

  1. Using CRIES scale to assess the pain level at 12 hours after postoperative awakening [12 hours after postoperative awakening]

    The pain score was evaluated 12 hours after Children wake up

Secondary Outcome Measures

  1. liver function [48 hours after surgery]

    alanine aminotransferase, aspartate aminotransferase

  2. renal function [48 hours after surgery]

    urea and creatinine values

  3. LOS [30 days after surgery]

    Length of stay after surgery

  4. Using CRIES scale to assess the pain level at 1 hour after postoperative awakening [1 hour after postoperative awakening]

    The pain score was evaluated 1 hour after Children wake up

  5. Using CRIES scale to assess the pain level at 6 hours after postoperative awakening [6 hours after postoperative awakening]

    The pain score was evaluated 6 hours after Children wake up

  6. Using CRIES scale to assess the pain level at 18 hours after postoperative awakening [18 hours after postoperative awakening]

    The pain score was evaluated 18 hours after Children wake up

  7. Using CRIES scale to assess the pain level at 24 hours after postoperative awakening [24 hours after postoperative awakening]

    The pain score was evaluated 24 hours after Children wake up

  8. Using CRIES scale to assess the pain level at 36 hours after postoperative awakening [36 hours after postoperative awakening]

    The pain score was evaluated 36 hours after Children wake up

  9. Using CRIES scale to assess the pain level at 48 hours after postoperative awakening [48 hours after postoperative awakening]

    The pain score was evaluated 48 hours after Children wake up

  10. Using FLACC scale to assess the pain level at 1 hour after postoperative awakening [1 hour after postoperative awakening]

    The pain score was evaluated 1 hour after Children wake up

  11. Using FLACC scale to assess the pain level at 6 hours after postoperative awakening [6 hours after postoperative awakening]

    The pain score was evaluated 6 hours after Children wake up

  12. Using FLACC scale to assess the pain level at 12 hours after postoperative awakening [12 hours after postoperative awakening]

    The pain score was evaluated 12 hours after Children wake up

  13. Using FLACC scale to assess the pain level at 18 hours after postoperative awakening [18 hours after postoperative awakening]

    The pain score was evaluated 18 hours after Children wake up

  14. Using FLACC scale to assess the pain level at 24 hours after postoperative awakening [24 hours after postoperative awakening]

    The pain score was evaluated 24 hours after Children wake up

  15. Using FLACC scale to assess the pain level at 36 hours after postoperative awakening [36 hours after postoperative awakening]

    The pain score was evaluated 36 hours after Children wake up

  16. Using FLACC scale to assess the pain level at 48 hours after postoperative awakening [48 hours after postoperative awakening]

    The pain score was evaluated 48 hours after Children wake up

  17. Using CHIPPS scale to assess the pain level at 1 hour after postoperative awakening [1 hour after postoperative awakening]

    The pain score was evaluated 1 hour after Children wake up

  18. Using CHIPPS scale to assess the pain level at 6 hours after postoperative awakening [6 hours after postoperative awakening]

    The pain score was evaluated 6 hours after Children wake up

  19. Using CHIPPS scale to assess the pain level at 12 hours after postoperative awakening [12 hours after postoperative awakening]

    The pain score was evaluated 12 hours after Children wake up

  20. Using CHIPPS scale to assess the pain level at 18 hours after postoperative awakening [18 hours after postoperative awakening]

    The pain score was evaluated 18 hours after Children wake up

  21. Using CHIPPS scale to assess the pain level at 24 hours after postoperative awakening [24 hours after postoperative awakening]

    The pain score was evaluated 24 hours after Children wake up

  22. Using CHIPPS scale to assess the pain level at 36 hours after postoperative awakening [36 hours after postoperative awakening]

    The pain score was evaluated 36 hours after Children wake up

  23. Using CHIPPS scale to assess the pain level at 48 hours after postoperative awakening [48 hours after postoperative awakening]

    The pain score was evaluated 48 hours after Children wake up

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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);

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Nanjing Medical University Nanjing Jiangsu China 210008

Sponsors and Collaborators

  • Nanjing Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weibing Tang, Chief of Department of neonatal surgery, Nanjing Children's Hospital
ClinicalTrials.gov Identifier:
NCT05564819
Other Study ID Numbers:
  • NCH202207156
First Posted:
Oct 4, 2022
Last Update Posted:
Oct 4, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2022