Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

Phase 4TerminatedNCT04541147

Duke University24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Pain, Postoperative

Interventions

AnalgesicsDRUG

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

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Opioid Use (Number of Doses)

Measured by medication log and units remaining.

Time frame: 4 weeks post-op

Average Pain Score

Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.

Time frame: 14 days post-op

Secondary Outcomes

Number of Participants With Post-operative Complications

Post-op re-admissions and emergency room visits.

Time frame: 30 days post-op