Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

• Status: Enrolling by invitation
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Analgesics; Dexamethasone

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