Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Under Enhanced Recovery After Surgery
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Using CRIES scale to assess the pain level at 12 hours after postoperative awakening
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 12 Months (Child)
- Sex
- 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);
Arms & Interventions
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.
Intervention: Acetaminophen (Drug)
placebo group
The same amount of sterilized water was administered orally at the same time points.
Intervention: Sterilized water (Drug)
Outcomes
Primary Outcomes
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
- LOS(30 days after surgery)
- Using CRIES scale to assess the pain level at 6 hours after postoperative awakening(6 hours after postoperative awakening)
- liver function(48 hours after surgery)
- renal function(48 hours after surgery)
- Using CRIES scale to assess the pain level at 1 hour after postoperative awakening(1 hour after postoperative awakening)
- Using CHIPPS scale to assess the pain level at 18 hours after postoperative awakening(18 hours after postoperative awakening)
- Using CHIPPS scale to assess the pain level at 36 hours after postoperative awakening(36 hours after postoperative awakening)
- Using CRIES scale to assess the pain level at 18 hours after postoperative awakening(18 hours after postoperative awakening)
- Using CRIES scale to assess the pain level at 24 hours after postoperative awakening(24 hours after postoperative awakening)
- Using CRIES scale to assess the pain level at 36 hours after postoperative awakening(36 hours after postoperative awakening)
- Using CRIES scale to assess the pain level at 48 hours after postoperative awakening(48 hours after postoperative awakening)
- Using FLACC scale to assess the pain level at 1 hour after postoperative awakening(1 hour after postoperative awakening)
- Using FLACC scale to assess the pain level at 6 hours after postoperative awakening(6 hours after postoperative awakening)
- Using FLACC scale to assess the pain level at 12 hours after postoperative awakening(12 hours after postoperative awakening)
- Using FLACC scale to assess the pain level at 18 hours after postoperative awakening(18 hours after postoperative awakening)
- Using FLACC scale to assess the pain level at 24 hours after postoperative awakening(24 hours after postoperative awakening)
- Using FLACC scale to assess the pain level at 36 hours after postoperative awakening(36 hours after postoperative awakening)
- Using FLACC scale to assess the pain level at 48 hours after postoperative awakening(48 hours after postoperative awakening)
- Using CHIPPS scale to assess the pain level at 1 hour after postoperative awakening(1 hour after postoperative awakening)
- Using CHIPPS scale to assess the pain level at 6 hours after postoperative awakening(6 hours after postoperative awakening)
- Using CHIPPS scale to assess the pain level at 12 hours after postoperative awakening(12 hours after postoperative awakening)
- Using CHIPPS scale to assess the pain level at 24 hours after postoperative awakening(24 hours after postoperative awakening)
- Using CHIPPS scale to assess the pain level at 48 hours after postoperative awakening(48 hours after postoperative awakening)
Investigators
Weibing Tang
Chief of Department of neonatal surgery
Nanjing Children's Hospital