Postoperative Oral Corticosteroids Following Tonsillectomy

NCT03352115 | Unknown

• 1 other identifier: 103717MP4F
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Tonsillectomy

Outcome Measures

Primary Outcomes (4)

• narcotics uses

  total amount of narcotic medication used in post-op period

  1 week

• non-narcotic pain medication used

  amount of acetaminophen and ibuprofen needed post-operatively

  1 week

• diet

  time to return to normal diet

  1 week

• activity

  time to return to normal activity level

  1 week

Secondary Outcomes (3)

• ED visits

  1 week

• dehydration

  1 week

• hemorrhage

  1 week

Study Arms (2)

Steroid group

EXPERIMENTAL

Will recieve 5 day course of oral prednisolone post-operatively

Drug: Prednisolone

Control

PLACEBO COMPARATOR

Will receive placebo syrup for 5 days post-operatively

Drug: Placebos

Interventions

Prednisolone DRUG

5 day course of oral prednisolone

Steroid group

Placebos DRUG

Placebo syrup

Control

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead
• Children's Hospital of Michigan Foundation: collaborator

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Bianca Siegel, MD

CONTACT

3137459048; bsiegel@dmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: November 24, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share