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Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

NCT04541147 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-12-27

Study results available
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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.

Conditions

  • Pain, Postoperative

Interventions

DRUG

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.

DRUG

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)

Sponsors & Collaborators

Principal Investigators

  • Eileen Raynor, MD · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2023-12-26
Completion
2023-12-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04541147 on ClinicalTrials.gov