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Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01415583
First Posted: August 12, 2011
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christopher Hartnick, M.D., Massachusetts Eye and Ear Infirmary
  Purpose

Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after tonsillectomy is one of the risks of this surgery and can be more dangerous in children since they have less blood volume than adults. In order to improve recovery after tonsillectomy, steroids (medication that is a strong anti-inflammatory) are often given during the surgery. Recently, a study showed steroids given at the time of tonsillectomy increase the risk of bleeding significantly over children who did not receive steroids. This finding has raised concerns in the Ear, Nose, and Throat (ENT) community since most ENT's use steroids during tonsillectomy in children. The investigators look to explore this question further.

To answer the question of whether perioperative steroid administration significantly affects the rate of post-tonsillectomy bleeding, the investigators propose to test the following hypotheses in a prospective, randomized, blinded placebo-controlled trial: dexamethasone does not cause an increase in post-operative bleeding rate in tonsillectomy.


Condition Intervention
Post-operative Hemorrhage Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

Resource links provided by NLM:


Further study details as provided by Christopher Hartnick, M.D., Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Number of Participants With Post-tonsillectomy Bleeding [ Time Frame: 2 weeks after surgery ]

Enrollment: 314
Actual Study Start Date: July 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline
Placebo is described in chart
Drug: Dexamethasone
0.5mg/kg (max dose 20mg)
Other Name: Decadron
Experimental: Dexamethasone
Dexamethasone is described in chart
Drug: Dexamethasone
0.5mg/kg (max dose 20mg)
Other Name: Decadron

Detailed Description:
Detailed description is entered above
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ages 3 to 18 undergoing tonsillectomy or adenotonsillectomy by electrocautery alone for the indication of sleep disordered breathing or infectious tonsillitis.
  • Patients with complex medical conditions or craniofacial abnormalities will be included.
  • Informed consent and child assent are required for enrollment.
  • Eligibility will be determined by the principal investigator, associate investigator or research nurse.

Exclusion Criteria:

  • Subjects with a known personal or family history of any bleeding disorder will be excluded.
  • Subjects currently on oral corticosteroids for other medical conditions or have recently taken any oral corticosteroid within two weeks of surgery.
  • Patients with tonsillectomy performed using a cold knife technique, microdebrider, coblation or plasma knife due to surgeon or parent preference.
  • Where appropriate subjects who do not have informed consent or child assent signed will be excluded
  • Children less than three years old will be excluded due to the fact the majority of these children at the collaborating centers have an adenotonsillectomy using the microdebrider for pain control purposes.
  Contacts and Locations
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): NCT01415583


Locations
United States, Massachusetts
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
Principal Investigator: Christopher Hartnick, MD Massachusetts Eye and Ear Infirmary
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Hartnick, M.D., Director, Division of Pediatric Otolaryngology, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01415583     History of Changes
Other Study ID Numbers: 10-03-016
First Submitted: October 27, 2010
First Posted: August 12, 2011
Results First Submitted: December 14, 2016
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Postoperative Hemorrhage
Pathologic Processes
Intraoperative Complications
Postoperative Complications
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action