Clinical trial NCT02990910: Individualized Analgesia After Adenotonsillectomy
Official title: Effects of an Individualized Analgesia Protocol on the Requirements of Medical Interventions After Adenotonsillectomy in Children Based on the Result of a Fentanyl Test: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: respiratory adverse events
adenotonsillectomy
opioid analgesia
children
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 280
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A high incidence of respiratory morbidity after adenotonsillectomy is reported in children with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind, randomized controlled study to determine the effects of individualized opioid analgesia compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy in Children with OSAS.

Detailed description: All children were randomized 2 groups based on a computer-generated random number. The main interventions were occurred in post anesthetic care unit (PACU). In the operating room, all patients received a standardized anesthetic regimen by one anesthetist. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl intravenous injection after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. The result of fentanyl test submitted to assistant, and prepared the rescue analgesic drugs according to this result. One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine. Another group: all received 25μg/kg morphine .The trachea was extubated when patients were awake, and then transported to the PACU. Patients with a Children's Hospital of Eastern Ontario Pain Scale score\>6 received rescue analgesic drugs and observe respiratory morbidity in each group.

Eligibility criteria: Inclusion Criteria:

* children with obstructive sleep apnea syndrome undergoing elective T\&A, ASA physical status I-II

Exclusion Criteria:

* developmental delay cardiac and craniofacial abnormalities ASA classification III or more body mass index more than the 95th percentile for age

Primary outcomes:
measure: The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events
timeFrame: Time from entering the PACU until the patient leaves,approx 1 hour.
Secondary outcomes:
measure: The Median Survival Time for CHEOPS Score > 6.
timeFrame: Time from entering the PACU until the patient leaves,approx 1 hour.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Chilren's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: xuan wang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo J, Zhuang P, Liu K, Wan Y, Wang X. Effects of an individualized analgesia protocol on the need for medical interventions after adenotonsillectomy in children: a randomized controlled trial. BMC Anesthesiol. 2021 Feb 8;21(1):41. doi: 10.1186/s12871-021-01263-3.