Individualized Analgesia After Adenotonsillectomy

NCT ID: NCT02990910

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-02-28

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.

Conditions

Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Individualized opioid analgesia

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

Group Type: OTHER

Individualized opioid analgesia

Intervention Type: DRUG

(a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.

conventional opioid analgesia

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

Group Type: OTHER

conventional opioid analgesia

Intervention Type: DEVICE

(b) all received 25μg/kg morphine

Interventions

Individualized opioid analgesia

(a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.

Intervention Type: DRUG

conventional opioid analgesia

(b) all received 25μg/kg morphine

Intervention Type: DEVICE

Other Intervention Names

IP; CP

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Xuan Wang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xuan wang

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Chilren's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33557762 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

IARA

Identifier Type: -

Identifier Source: org_study_id