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NCT Number: NCT05564819

Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants

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.

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Key information

Conditions

Analgesic Acetaminophen Enhanced Recovery After Surgery Infant ALL Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

Acetaminophen

Drug

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

Drug

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.

Primary outcomes

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

    Time frame: 12 hours after postoperative awakening

    The pain score was evaluated 12 hours after Children wake up

Secondary outcomes

  1. liver function

    Time frame: 48 hours after surgery

    alanine aminotransferase, aspartate aminotransferase

  2. renal function

    Time frame: 48 hours after surgery

    urea and creatinine values

  3. LOS

    Time frame: 30 days after surgery

    Length of stay after surgery

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 48 hours after postoperative awakening

    The pain score was evaluated 48 hours after Children wake up

Sponsors and collaborators

Lead sponsor

Nanjing Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2022
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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