Status:

UNKNOWN

Postoperative Oral Corticosteroids Following Tonsillectomy

Lead Sponsor:

Wayne State University

Collaborating Sponsors:

Children's Hospital of Michigan Foundation

Conditions:

Tonsillectomy

Eligibility:

All Genders

4-18 years

Phase:

NA

Brief Summary

Tonsillectomy is one of the most common surgical procedures in the United States, and post-operative pain management is a challenge for otolaryngologists. A 2013 black-box warning on codeine following...

Detailed Description

I. Background Tonsillectomy is one of the most common surgical procedures in the United States with the predominant indications being obstructive sleep apnea and recurrent tonsillitis1. While it is u...

Eligibility Criteria

Inclusion

  • Subject is male or female age 4-18 years of age
  • Patients undergoing total tonsillectomy with or without adenoidectomy or tympanostomy tubes
  • Patients with obstructive sleep apnea or recurrent tonsillitis requiring tonsillectomy.
  • The patient or caregiver is able to provide written informed consent.
  • Patients with American Society of Anesthesiologist (ASA) physical status 1 or 2.

Exclusion

  • Subjects with complex medical conditions or craniofacial abnormalities
  • Subjects with known personal or family history of bleeding disorder
  • Subjects with cognitive or developmental disorders
  • Subjects currently taking corticosteroids for other medical conditions, or who have taken corticosteroids within 2 weeks of surgery
  • Subjects who are wards of the state
  • Subjects who have had an organ transplant
  • Subjects who are on other immunosuppressant medications
  • Subjects with diabetes mellitus
  • Non-English Speakers or English as a second language
  • Subjects undergoing intracapsular tonsillectomy
  • Subjects with American Society of Anesthesiologist (ASA) physical status greater than 2.
  • Pregnancy

Key Trial Info

Start Date :

January 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2019

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT03352115

Start Date

January 1 2018

End Date

January 1 2019

Last Update

November 24 2017

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