Clinical trial

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

Name

Pro00103025

Description

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.

Trial arms

Trial start

2021-04-14

Estimated PCD

2023-12-26

Trial end

2023-12-26

Status

Terminated

Phase

Early phase I

Treatment

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.

Arms:

Dexamethasone plus analgesics

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)

Arms:

Dexamethasone plus analgesics, analgesics alone

Size

Primary endpoint

Opioid use

4 weeks post-op

change in pain score

twice daily from surgery to 14 days post-op

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

Updated at

2024-02-28

1 organization

1 product

1 drug

2 indications

Organization

Drug

Indication

Indication

Product