Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity

Summary

The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. A double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus placebo postoperatively will be performed. Investigators will determine if there is a difference in post-operative pain and complications between groups.

Conditions

• Adenotonsillectomy
• Analgesia
• Surgery

Interventions

DRUG

Dexamethasone

IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup

DRUG

Ibuprofen

Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.

DRUG

Acetaminophen

Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.

DRUG

Placebo

An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup.

Sponsors & Collaborators

• David Chi, MD

  lead OTHER

Principal Investigators

• David H. Chi, MD · Clinical Director, Division of Pediatric Otolaryngology, UPMC Children's Hospital of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-05

Primary Completion

2023-07-11

Completion

2023-07-11

FDA Drug

Yes

Countries

• United States

Study Locations