Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

Phase 4

Terminated

• Conditions: Pain, Postoperative
• Interventions: Drug: Dexamethasone; Drug: Analgesics

• Registration Number: NCT04541147
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Study Start: 2021-04-14
• Primary Completion: 2023-12-26
• Study Completion: 2023-12-26
• Status Verified: 2024-12
• Results First Submitted: 2024-12-04
• Results First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Results First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Age 4-17 years at time of surgery
• Scheduled for tonsillectomy or adenotonsillectomy surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone plus analgesics	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).
analgesics alone	Analgesics	standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Dexamethasone plus analgesics	Dexamethasone	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).

Primary Outcome Measures

Name	Time	Method
Opioid Use (Number of Doses)	4 weeks post-op	Measured by medication log and units remaining.
Average Pain Score	14 days post-op	Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Post-operative Complications	30 days post-op	Post-op re-admissions and emergency room visits.

Trial Locations

Locations (1)

Duke University Medical Center and affiliated practices; 🇺🇸 Durham, North Carolina, United States