Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

A Randomized Control Trial of Post-operative Course of Oral Dexamethasone and Effect on Opioid Usage in Pediatric Tonsillectomies in a Tertiary Care Center

Sponsors

Lead Sponsor: Duke University

Source 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.

Overall Status Not yet recruiting
Start Date September 30, 2020
Completion Date December 30, 2021
Primary Completion Date December 30, 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Opioid use 4 weeks post-op
change in pain score twice daily from surgery to 14 days post-op
Secondary Outcome
Measure Time Frame
Number of post-operative complications 30 days post-op
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: 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.

Arm Group Label: Dexamethasone plus analgesics

Intervention Type: Drug

Intervention Name: Analgesics

Description: 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

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

Gender: All

Minimum Age: 4 Years

Maximum Age: 17 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Eileen Raynor, MD Principal Investigator Duke University Health System
Overall Contact

Last Name: Amy Walker

Phone: 919-684-1732

Email: [email protected]

Location
Facility: Contact: Investigator: Duke University Medical Center and affiliated practices Amy Walker 919-684-1732 [email protected] Eileen Raynor, MD Principal Investigator
Location Countries

United States

Verification Date

August 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Dexamethasone plus analgesics

Type: Experimental

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).

Label: analgesics alone

Type: Active Comparator

Description: standardized course of analgesics (opioids/acetaminophen/NSAIDs)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov