Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients
Primary Purpose
Pain, Postoperative
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Analgesics
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria:
- Age 4-17 years at time of surgery
- Scheduled for tonsillectomy or adenotonsillectomy surgery
Exclusion Criteria:
- Prior history of intracapsular tonsillectomy
- Previous diagnoses of Down Syndrome or developmental delay
- Presence of gastrostomy (g) tube
- A contraindication to steroids or steroid usage within 30 days prior to surgery including diabetes, allergy to steroid, already on chronic steroid, immune deficiency
- Active infection or concurrent operative procedures at the time of surgery
- Unable to read or speak English
- Pregnant or breastfeeding females
Sites / Locations
- Duke University Medical Center and affiliated practices
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dexamethasone plus analgesics
analgesics alone
Arm Description
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Outcomes
Primary Outcome Measures
Opioid use
measured by medication log and units remaining
change in pain score
measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.
Secondary Outcome Measures
Number of post-operative complications
Measured by post-op re-admissions and emergency room visits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04541147
Brief Title
Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients
Official Title
A Randomized Control Trial of Post-operative Course of Oral Dexamethasone and Effect on Opioid Usage in Pediatric Tonsillectomies in a Tertiary Care Center
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy.
Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment.
Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone plus analgesics
Arm Type
Experimental
Arm Description
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Arm Title
analgesics alone
Arm Type
Active Comparator
Arm Description
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
Intervention Type
Drug
Intervention Name(s)
Analgesics
Intervention Description
standardization of post-operative analgesics (narcotics and non-narcotic medication).
Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
Primary Outcome Measure Information:
Title
Opioid use
Description
measured by medication log and units remaining
Time Frame
4 weeks post-op
Title
change in pain score
Description
measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.
Time Frame
twice daily from surgery to 14 days post-op
Secondary Outcome Measure Information:
Title
Number of post-operative complications
Description
Measured by post-op re-admissions and emergency room visits
Time Frame
30 days post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 4-17 years at time of surgery
Scheduled for tonsillectomy or adenotonsillectomy surgery
Exclusion Criteria:
Prior history of intracapsular tonsillectomy
Previous diagnoses of Down Syndrome or developmental delay
Presence of gastrostomy (g) tube
A contraindication to steroids or steroid usage within 30 days prior to surgery including diabetes, allergy to steroid, already on chronic steroid, immune deficiency
Active infection or concurrent operative procedures at the time of surgery
Unable to read or speak English
Pregnant or breastfeeding females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen Raynor, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center and affiliated practices
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients
We'll reach out to this number within 24 hrs