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Postoperative Oral Corticosteroids Following Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03352115
Recruitment Status : Not yet recruiting
First Posted : November 24, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Children's Hospital of Michigan Foundation
Information provided by (Responsible Party):
Bianca Siegel, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Tonsillectomy Drug: Prednisolone Drug: Placebos Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-operative Oral Corticosteroids Following Tonsillectomy: A Randomized Controlled Trial
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids Tonsillitis

Arm Intervention/treatment
Experimental: Steroid group
Will recieve 5 day course of oral prednisolone post-operatively
Drug: Prednisolone
5 day course of oral prednisolone

Placebo Comparator: Control
Will receive placebo syrup for 5 days post-operatively
Drug: Placebos
Placebo syrup




Primary Outcome Measures :
  1. narcotics uses [ Time Frame: 1 week ]
    total amount of narcotic medication used in post-op period

  2. non-narcotic pain medication used [ Time Frame: 1 week ]
    amount of acetaminophen and ibuprofen needed post-operatively

  3. diet [ Time Frame: 1 week ]
    time to return to normal diet

  4. activity [ Time Frame: 1 week ]
    time to return to normal activity level


Secondary Outcome Measures :
  1. ED visits [ Time Frame: 1 week ]
    rate of ED visits post-op

  2. dehydration [ Time Frame: 1 week ]
    rate of readmission for dehydration

  3. hemorrhage [ Time Frame: 1 week ]
    post-op hemorrhage rate



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352115


Contacts
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Contact: Bianca Siegel, MD 3137459048 bsiegel@dmc.org

Sponsors and Collaborators
Wayne State University
Children's Hospital of Michigan Foundation

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Responsible Party: Bianca Siegel, Assistant Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT03352115     History of Changes
Other Study ID Numbers: 103717MP4F
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents