Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients
NCT ID: NCT04541147
Last Updated: 2024-12-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
24 participants
INTERVENTIONAL
2021-04-14
2023-12-26
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Dexamethasone plus analgesics
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).
Dexamethasone
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.
Analgesics
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)
analgesics alone
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Analgesics
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)
Interventions
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Dexamethasone
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.
Analgesics
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)
Eligibility Criteria
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Inclusion Criteria
* Scheduled for tonsillectomy or adenotonsillectomy surgery
Exclusion Criteria
* 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
4 Years
17 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Eileen Raynor, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Duke University Medical Center and affiliated practices
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Pro00103025
Identifier Type: -
Identifier Source: org_study_id