Pediatric Pain Optimization After Tonsillectomy
Primary Purpose
Obstructive Sleep Apnea, Tonsillitis, Pain, Procedural
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fentanyl/Hydromorphone
Methadone
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Children ages 3 to 17 years old years
- Presenting for elective tonsillectomy +/- adenoidectomy
- Provide informed consent / assent (as appropriate)
Exclusion Criteria:
- History of liver or kidney disease
- Females with positive pregnancy test
- Severe sleep apnea (Sleep study with Apnea Hypopnea Index (AHI) > 10)
- Consistent daily opioid use for chronic pain ( >3 months)
Sites / Locations
- Duke University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Short acting opioids: Fentanyl, Hydromorphone
Long Acting Opioid: Methadone
Arm Description
Outcomes
Primary Outcome Measures
Total amount of opioid medications administered - short acting opioid group
Postoperative opioid medication expressed in morphine equivalents per kilogram
Total amount of opioid medications administered - long acting opioid group
Postoperative opioid medication expressed in morphine equivalents per kilogram
Secondary Outcome Measures
Evaluation of participant's pain - short acting opioid group
Parent Post operative Pain Measure (PPPM) 15 yes/no questions which results in a score from 0-15. A score of at least 6 out of 15 signifies clinically significant pain.
Evaluation of participant's pain - long acting opioid group
Parent Post operative Pain Measure (PPPM) 15 yes/no questions which results in a score from 0-15. A score of at least 6 out of 15 signifies clinically significant pain.
NIH PROMIS Parent Proxy Report Scale - short acting opioid group
Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
NIH PROMIS Parent Proxy Report Scale - long acting opioid group
Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
Evaluation of participant's pain - short acting opioid group
Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Evaluation of participant's pain - long acting opioid group
Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Prescription opioid use following hospital discharge - short acting opioid group
Number of doses of prescription medication used, 0 doses-all doses in prescription
Prescription opioid use following hospital discharge - long acting opioid group
Number of doses of prescription medication used, 0 doses-all doses in prescription
Opioid administration in the PACU - short acting opioid group
Opioid medication use in the recovery room expressed in morphine equivalents per kilogram
Opioid administration in the PACU - long acting opioid group
Opioid medication use in the recovery room expressed in morphine equivalents per kilogram
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05244226
Brief Title
Pediatric Pain Optimization After Tonsillectomy
Official Title
Pediatric Pain Optimization After Tonsillectomy: A Randomized Double Blind Methadone Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the use of short acting opioids (fentanyl/hydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery.
Detailed Description
This is a single center, randomized, double blind, parallel-group dose escalation investigation which will compare post operative pain control indices for patients receiving short acting versus long acting opioids as intraoperative analgesics. Surgical and anesthesia care, except for intraoperative opioid management, are not altered for study purposes. Subjects are randomized 2:1 to either long-duration (methadone) or short-duration opioid (fentanyl, hydromorphone) through the perioperative period. Exploratory data will be collected for up to 30 days post-operatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Tonsillitis, Pain, Procedural
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short acting opioids: Fentanyl, Hydromorphone
Arm Type
Active Comparator
Arm Title
Long Acting Opioid: Methadone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fentanyl/Hydromorphone
Intervention Description
Per routine care
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
Initial dosing 0.1mg/kg, potential to escalate to 0.15mg/kg following interim analysis
Primary Outcome Measure Information:
Title
Total amount of opioid medications administered - short acting opioid group
Description
Postoperative opioid medication expressed in morphine equivalents per kilogram
Time Frame
Up to 7 days post surgery
Title
Total amount of opioid medications administered - long acting opioid group
Description
Postoperative opioid medication expressed in morphine equivalents per kilogram
Time Frame
Up to 7 days post surgery
Secondary Outcome Measure Information:
Title
Evaluation of participant's pain - short acting opioid group
Description
Parent Post operative Pain Measure (PPPM) 15 yes/no questions which results in a score from 0-15. A score of at least 6 out of 15 signifies clinically significant pain.
Time Frame
Up to 7 days post surgery
Title
Evaluation of participant's pain - long acting opioid group
Description
Parent Post operative Pain Measure (PPPM) 15 yes/no questions which results in a score from 0-15. A score of at least 6 out of 15 signifies clinically significant pain.
Time Frame
Up to 7 days post surgery
Title
NIH PROMIS Parent Proxy Report Scale - short acting opioid group
Description
Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
Time Frame
Up to 7 days post surgery
Title
NIH PROMIS Parent Proxy Report Scale - long acting opioid group
Description
Patient caregiver satisfaction, behavior and pain scores over past 7 days. Scale of 1 - 6, with 1=had no pain and 6=almost always
Time Frame
Up to 7 days post surgery
Title
Evaluation of participant's pain - short acting opioid group
Description
Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Time Frame
Up to 7 days post surgery
Title
Evaluation of participant's pain - long acting opioid group
Description
Numeric Pain Rating Scale, 0-10. 0 no pain, 10 worst possible pain
Time Frame
Up to 7 days post surgery
Title
Prescription opioid use following hospital discharge - short acting opioid group
Description
Number of doses of prescription medication used, 0 doses-all doses in prescription
Time Frame
Up to 7 days post surgery
Title
Prescription opioid use following hospital discharge - long acting opioid group
Description
Number of doses of prescription medication used, 0 doses-all doses in prescription
Time Frame
Up to 7 days post surgery
Title
Opioid administration in the PACU - short acting opioid group
Description
Opioid medication use in the recovery room expressed in morphine equivalents per kilogram
Time Frame
Up to 6 hours post surgery
Title
Opioid administration in the PACU - long acting opioid group
Description
Opioid medication use in the recovery room expressed in morphine equivalents per kilogram
Time Frame
Up to 6 hours post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children ages 3 to 17 years old years
Presenting for elective tonsillectomy +/- adenoidectomy
Provide informed consent / assent (as appropriate)
Exclusion Criteria:
History of liver or kidney disease
Females with positive pregnancy test
Severe sleep apnea (Sleep study with Apnea Hypopnea Index (AHI) > 10)
Consistent daily opioid use for chronic pain ( >3 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Einhorn, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pediatric Pain Optimization After Tonsillectomy
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