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Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT01415583
First received: October 27, 2010
Last updated: April 19, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Number of participants with post-tonsillectomy bleeding [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: Yes ]
    The primary objective of this study is to determine if dexamethasone at 0.5mg/kg (max dose 20mg) is associated with an increased rate of post-tonsillectomy hemorrhage in children when compared to placebo.


Secondary Outcome Measures:
  • To compare rate of post-tonsillectomy hemorrhage when studying different groups of patients based on age, indication for surgery, or operating surgeon. [ Time Frame: 2 weeks after surgery ] [ Designated as safety issue: Yes ]
    The second objective of this study is to use a multivariate logistic regression model to determine if bleeding rates differed according to surgical indication, age, or operating surgeon. This is important since indication for tonsillectomy varies in children. Younger children tend to undergo tonsillectomy for obstructive sleep symptoms whereas older children tend to have the indication for tonsillectomy based on infectious tonsillitis.


Enrollment: 314
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 Drug: Dexamethasone
0.5mg/kg (max dose 20mg)
Other Name: Decadron
Experimental: Dexamethasone Drug: Dexamethasone
0.5mg/kg (max dose 20mg)
Other Name: Decadron

Detailed Description:

Not desired

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Massachusetts Eye and Ear Infirmary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT01415583     History of Changes
Other Study ID Numbers: 10-03-016
Study First Received: October 27, 2010
Last Updated: April 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Postoperative Complications
Intraoperative Complications
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013