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Individualized Analgesia After Adenotonsillectomy

Primary Purpose

Analgesia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Individualized opioid analgesia
conventional opioid analgesia
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Analgesia focused on measuring respiratory adverse events, adenotonsillectomy, opioid analgesia, children

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Chilren's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Individualized opioid analgesia

conventional opioid analgesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

The Median Survival Time for CHEOPS Score > 6.
Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS>6 in two groups.

Full Information

First Posted
December 7, 2016
Last Updated
July 13, 2020
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02990910
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
respiratory adverse events, adenotonsillectomy, opioid analgesia, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized opioid analgesia
Arm Type
Other
Arm Description
One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
Arm Title
conventional opioid analgesia
Arm Type
Other
Arm Description
Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.
Intervention Type
Drug
Intervention Name(s)
Individualized opioid analgesia
Other Intervention Name(s)
IP
Intervention Description
(a)positive result 10μg/kg morphine; negative result 50μg/kg morphine.
Intervention Type
Device
Intervention Name(s)
conventional opioid analgesia
Other Intervention Name(s)
CP
Intervention Description
(b) all received 25μg/kg morphine
Primary Outcome Measure Information:
Title
The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events
Description
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 Frame
Time from entering the PACU until the patient leaves,approx 1 hour.
Secondary Outcome Measure Information:
Title
The Median Survival Time for CHEOPS Score > 6.
Description
Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS>6 in two groups.
Time Frame
Time from entering the PACU until the patient leaves,approx 1 hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xuan wang
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chilren's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33557762
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.
Results Reference
derived

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Individualized Analgesia After Adenotonsillectomy

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