NCT02990910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
6 months until next milestone

Results Posted

Study results publicly available

August 9, 2017

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

December 7, 2016

Results QC Date

June 1, 2017

Last Update Submit

July 13, 2020

Conditions

Analgesia

Keywords

respiratory adverse eventsadenotonsillectomyopioid analgesiachildren

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events

    The medical interventions included instrumentation of the airway, bag/mask ventilation, and/or drug administration (succinylcholine, albuterol, or naloxone), which were classified as major medical interventions. The medical interventions also included repositioning of the child's airway, chin lift/jaw thrust maneuvers, and/or escalating to an oxygen mask, which were classified as minor medical interventions. Since oxygen by nasal cannula was delivered to all children recovering from anesthesia, escalating to an oxygen mask implied the patient need but higher concentration of oxygen to maintain SpO2 ≥ 95%.

    Time from entering the PACU until the patient leaves,approx 1 hour.

Secondary Outcomes (1)

  • The Median Survival Time for CHEOPS Score > 6.

    Time from entering the PACU until the patient leaves,approx 1 hour.

Study Arms (2)

Individualized opioid analgesia

OTHER

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

Drug: Individualized opioid analgesia

conventional opioid analgesia

OTHER

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

Device: conventional opioid analgesia

Interventions

Individualized opioid analgesiaDRUG

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

Also known as: IP
Individualized opioid analgesia
conventional opioid analgesiaDEVICE

(b) all received 25μg/kg morphine

Also known as: CP
conventional opioid analgesia

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chilren's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

  • 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.

    PMID: 33557762DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

The absence of PSG assessment before surgery in patients recruited in this study is a limitation.

Results Point of Contact

Title
Dr.Wang Xuan
Organization
the Children's Hospital of Fudan University
744734170@qq.com
18017591058

Study Officials

  • xuan wang

    Children's Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 13, 2016

Study Start

November 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

July 21, 2020

Results First Posted

August 9, 2017

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)