Clinical trial NCT04527393: Individualized Analgesia for Pediatric Adenotonsillectomy
Official title: Effects of Individualized Opioid Analgesia Versus Conventional Opioid Analgesia After Adenotonsillectomy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adenotonsillectomy
Analgesia
Keywords: adenotonsillectomy
individualized opioid analgesia
respiratory parameters
children
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 542
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized clinical trial is to assess the safety and effectiveness of post-adenotonsillectomy analgesia with individualized opioid analgesia regime in children.

Detailed description: Patients will be randomly assigned to individualized opioid analgesia regimen group or conventional opioid analgesia regimen group.

Intravenous 1μg/kg fentanyl is administered as a test in patients with spontaneous breath after sevoflurane induction. A positive result is defined as a decrease of more than 50% in spontaneous respiratory rate (rate after fentanyl test versus rate before fentanyl test). Otherwise it is defined as a negative result.

All the patients are given regular paracetamol and ibuprofen after surgery. The addition of rescue oral morphine is given as needed. The dose of oral morphine is determined according to the results of fentanyl test in the individualized group, while the patients in the conventional group are given the routine dose. The Faces Scale is used to assess analgesic effectiveness by parents from postoperative day 1 to day 10. If the Faces Scale score \> 6, the child receive rescue oral morphine analgesia.

At the preoperative appointment, parents are provided with a pulse oximeter including oxygen saturation sensors to take home. The oxygen saturation per night during sleep will be monitored using the pulse oximeter by parents from postoperative Day 1 to Day 10. The research team will instruct parents on how to properly apply the oximeter to the child and repeat these measurements. The primary outcome measure is desaturation events during sleep per night.

Eligibility criteria: Inclusion Criteria:

* Children, ASA physical status I or II, who is scheduled to undergo adenotonsillectomy will be recruited.

Exclusion Criteria:

* Children with craniofacial deformities, neuromuscular diseases, mental retardation, body mass index \> 30kg/m2 , or a recent history of opioid use are excluded.

Primary outcomes:
measure: Desaturation events
timeFrame: from postoperative day 1 to day 10, each night
Secondary outcomes:
measure: Scores of Pain Scale (the Faces Scale)
timeFrame: every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day)
measure: Scores of Pain Scale (the Objective Pain Scale)
timeFrame: every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day)
measure: Tonsillar bleeding events
timeFrame: from postoperative day 1 to day 10
measure: Adverse drug reactions
timeFrame: from postoperative day 1 to day 10
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
Study officials:
References: