Back to resultsContinuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children
Primary Purpose
Sleep Breathing Disorders, Tonsillitis, Adenoid Hypertrophy
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion
continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion
continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion
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About this trial
This is an interventional treatment trial for Sleep Breathing Disorders
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists grade I or II children aged 5-8 years undergoing coblation tonsillectomy or adeno-tonsillectomy as in-patient
Exclusion Criteria:
- Children with a history of adverse reaction to opioids, long-term use of opioid medications, and history of chronic pain.
- Psychiatric illness, kidney failure, hypotension, atrioventricular block, myasthenia gravis etc.
Sites / Locations
- Guangzhou Women and Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Sufentanil infusion rate 0.02μg•kg-1•h-1
Sufentanil infusion rate 0.03μg•kg-1•h-1
Sufentanil infusion rate 0.04μg•kg-1•h-1
Arm Description
Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours
Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours
Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours
Outcomes
Primary Outcome Measures
objective pain score
Secondary Outcome Measures
incidence rate of hypoxia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02205580
Brief Title
Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children
Official Title
Comparison of Three Different Rates of Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Coblation Tonsillectomy or Adeno-tonsillectomy in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jin Ni
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in children. There are few reports about its use for postoperative analgesia by continuous intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or vomiting.
The investigators design this protocol to test efficacy of analgesia of three different rates of continuous intravenous sufentanil infusion for postoperative pain management following coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare incidence rate of complications for three groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Breathing Disorders, Tonsillitis, Adenoid Hypertrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sufentanil infusion rate 0.02μg•kg-1•h-1
Arm Type
Experimental
Arm Description
Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours
Arm Title
Sufentanil infusion rate 0.03μg•kg-1•h-1
Arm Type
Experimental
Arm Description
Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours
Arm Title
Sufentanil infusion rate 0.04μg•kg-1•h-1
Arm Type
Experimental
Arm Description
Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours
Intervention Type
Drug
Intervention Name(s)
continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion
Intervention Type
Drug
Intervention Name(s)
continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion
Intervention Type
Drug
Intervention Name(s)
continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion
Primary Outcome Measure Information:
Title
objective pain score
Time Frame
up to 48 hours after operation
Secondary Outcome Measure Information:
Title
incidence rate of hypoxia
Time Frame
4h,8h,24h,48h after operation
Other Pre-specified Outcome Measures:
Title
incidence rate of pruritus
Time Frame
4h,8h,24h,48h after operation
Title
incidence rate of nausea and/or vomiting
Time Frame
4h,8h,24h,48h after operation
Title
incidence rate of sedation
Time Frame
4h,8h,24h,48h after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists grade I or II children aged 5-8 years undergoing coblation tonsillectomy or adeno-tonsillectomy as in-patient
Exclusion Criteria:
Children with a history of adverse reaction to opioids, long-term use of opioid medications, and history of chronic pain.
Psychiatric illness, kidney failure, hypotension, atrioventricular block, myasthenia gravis etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Ni, M.D.
Organizational Affiliation
Guangzhou Women and Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Women and Children's Medical Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510623
Country
China
12. IPD Sharing Statement
Learn more about this trial
Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children
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