Individualized Analgesia After Adenotonsillectomy

Fudan University

Status: Completed

Conditions: Analgesia

Treatments: Device: conventional opioid analgesia; Drug: Individualized opioid analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02990910

IARA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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280 participants in 2 patient groups

Individualized opioid analgesia

Other group

Description:

One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9.

Treatment:

Drug: Individualized opioid analgesia

conventional opioid analgesia

Other group

Description:

Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS\<=6 and Aldrete score\>9.

Treatment:

Device: conventional opioid analgesia