Postoperative Oral Corticosteroids Following Tonsillectomy

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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 tonsillectomy has drawn attention to potential concerns with all narcotics in these patients, and many surgeons try to avoid narcotics. The use of intra-operative corticosteroids has been proven to be beneficial in reducing post-operative morbidity, and some small studies have shown possible benefit to the use of post-operative oral corticosteroids as well, although the results of these studies are mixed. To date, no one has looked at whether the use of post-operative oral steroids may reduce or eliminate the need for narcotics. We aim to determine whether the addition of oral steroids to our post-operative pain regimen can reduce the need for narcotic pain medications.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wayne State University
• Collaborator: Children's Hospital of Michigan Foundation
• Treatments: Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. Subject is male or female age 4-18 years of age

2. Patients undergoing total tonsillectomy with or without adenoidectomy or tympanostomy tubes

3. Patients with obstructive sleep apnea or recurrent tonsillitis requiring tonsillectomy.

4. The patient or caregiver is able to provide written informed consent.

5. Patients with American Society of Anesthesiologist (ASA) physical status 1 or 2.

Exclusion Criteria:

1. Subjects with complex medical conditions or craniofacial abnormalities

2. Subjects with known personal or family history of bleeding disorder

3. Subjects with cognitive or developmental disorders

4. Subjects currently taking corticosteroids for other medical conditions, or who have taken corticosteroids within 2 weeks of surgery

5. Subjects who are wards of the state

6. Subjects who have had an organ transplant

7. Subjects who are on other immunosuppressant medications

8. Subjects with diabetes mellitus

9. Non-English Speakers or English as a second language

10. Subjects undergoing intracapsular tonsillectomy

11. Subjects with American Society of Anesthesiologist (ASA) physical status greater than 2.

12. Pregnancy