Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

Duke University

Status and phase: Terminated; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Dexamethasone; Drug: Analgesics

Study type: Interventional

Funder types: Other

Identifiers

NCT04541147

Pro00103025

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Dexamethasone plus analgesics

Experimental group

Description:

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).

Treatment:

Drug: Analgesics

Drug: Dexamethasone

analgesics alone

Active Comparator group

Description:

standardized course of analgesics (opioids/acetaminophen/NSAIDs)

Treatment:

Drug: Analgesics