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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05564819
Enrollment
220
Registered
2022-10-04
Start date
2022-09-14
Completion date
2023-07-31
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGAcetaminophen

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.

DRUGSterilized 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.

Sponsors

Nanjing Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 12 Months
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);

Design outcomes

Primary

MeasureTime frameDescription
Using CRIES scale to assess the pain level at 12 hours after postoperative awakening12 hours after postoperative awakeningThe pain score was evaluated 12 hours after Children wake up

Secondary

MeasureTime frameDescription
renal function48 hours after surgeryurea and creatinine values
LOS30 days after surgeryLength of stay after surgery
Using CRIES scale to assess the pain level at 1 hour after postoperative awakening1 hour after postoperative awakeningThe pain score was evaluated 1 hour after Children wake up
Using CRIES scale to assess the pain level at 6 hours after postoperative awakening6 hours after postoperative awakeningThe pain score was evaluated 6 hours after Children wake up
Using CRIES scale to assess the pain level at 18 hours after postoperative awakening18 hours after postoperative awakeningThe pain score was evaluated 18 hours after Children wake up
Using CRIES scale to assess the pain level at 24 hours after postoperative awakening24 hours after postoperative awakeningThe pain score was evaluated 24 hours after Children wake up
Using CRIES scale to assess the pain level at 36 hours after postoperative awakening36 hours after postoperative awakeningThe pain score was evaluated 36 hours after Children wake up
Using CRIES scale to assess the pain level at 48 hours after postoperative awakening48 hours after postoperative awakeningThe pain score was evaluated 48 hours after Children wake up
Using FLACC scale to assess the pain level at 1 hour after postoperative awakening1 hour after postoperative awakeningThe pain score was evaluated 1 hour after Children wake up
Using FLACC scale to assess the pain level at 6 hours after postoperative awakening6 hours after postoperative awakeningThe pain score was evaluated 6 hours after Children wake up
Using FLACC scale to assess the pain level at 12 hours after postoperative awakening12 hours after postoperative awakeningThe pain score was evaluated 12 hours after Children wake up
liver function48 hours after surgeryalanine aminotransferase, aspartate aminotransferase
Using FLACC scale to assess the pain level at 24 hours after postoperative awakening24 hours after postoperative awakeningThe pain score was evaluated 24 hours after Children wake up
Using FLACC scale to assess the pain level at 36 hours after postoperative awakening36 hours after postoperative awakeningThe pain score was evaluated 36 hours after Children wake up
Using FLACC scale to assess the pain level at 48 hours after postoperative awakening48 hours after postoperative awakeningThe pain score was evaluated 48 hours after Children wake up
Using CHIPPS scale to assess the pain level at 1 hour after postoperative awakening1 hour after postoperative awakeningThe pain score was evaluated 1 hour after Children wake up
Using CHIPPS scale to assess the pain level at 6 hours after postoperative awakening6 hours after postoperative awakeningThe pain score was evaluated 6 hours after Children wake up
Using CHIPPS scale to assess the pain level at 12 hours after postoperative awakening12 hours after postoperative awakeningThe pain score was evaluated 12 hours after Children wake up
Using CHIPPS scale to assess the pain level at 18 hours after postoperative awakening18 hours after postoperative awakeningThe pain score was evaluated 18 hours after Children wake up
Using CHIPPS scale to assess the pain level at 24 hours after postoperative awakening24 hours after postoperative awakeningThe pain score was evaluated 24 hours after Children wake up
Using CHIPPS scale to assess the pain level at 36 hours after postoperative awakening36 hours after postoperative awakeningThe pain score was evaluated 36 hours after Children wake up
Using CHIPPS scale to assess the pain level at 48 hours after postoperative awakening48 hours after postoperative awakeningThe pain score was evaluated 48 hours after Children wake up
Using FLACC scale to assess the pain level at 18 hours after postoperative awakening18 hours after postoperative awakeningThe pain score was evaluated 18 hours after Children wake up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026