Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04541147
• Other study ID #: Pro00103025
• Status: Terminated
• Phase: Phase 4
• Start date: April 14, 2021
• Est. completion date: December 26, 2023

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 26, 2023
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• 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)

Locations

Country	Name	City	State
United States	Duke University Medical Center and affiliated practices	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid use	measured by medication log and units remaining	4 weeks post-op
Primary	change in pain score	measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.	twice daily from surgery to 14 days post-op
Secondary	Number of post-operative complications	Measured by post-op re-admissions and emergency room visits	30 days post-op