We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

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.
ClinicalTrials.gov Identifier: NCT01415583
Recruitment Status : Completed
First Posted : August 12, 2011
Results First Posted : July 12, 2017
Last Update Posted : July 12, 2017
Information provided by (Responsible Party):
Christopher Hartnick, M.D., Massachusetts Eye and Ear Infirmary

Brief Summary:

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 or disease Intervention/treatment
Post-operative Hemorrhage Drug: Dexamethasone

Detailed Description:
Detailed description is entered above

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 314 participants
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
Actual Study Start Date : July 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Tonsillitis
U.S. FDA Resources

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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

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

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 Posted: August 12, 2011    Key Record Dates
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:
Blood Loss, Surgical
Postoperative Hemorrhage
Pathologic Processes
Intraoperative Complications
Postoperative Complications
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action