Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Hemorrhage
• Intervention / Treatment: Drug: Dexamethasone

Detailed Description

Detailed description is entered above

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; Placebo is described in chart	Drug: Dexamethasone; 0.5mg/kg (max dose 20mg); Other Names: Decadron
Experimental: Dexamethasone; Dexamethasone is described in chart	Drug: Dexamethasone; 0.5mg/kg (max dose 20mg); Other Names: Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Post-tonsillectomy Bleeding	2 weeks after surgery

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary

Publications and helpful links

General Publications

• Gallagher TQ, Hill C, Ojha S, Ference E, Keamy DG, Williams M, Hansen M, Maurer R, Collins C, Setlur J, Capra GG, Brigger MT, Hartnick CJ. Perioperative dexamethasone administration and risk of bleeding following tonsillectomy in children: a randomized controlled trial. JAMA. 2012 Sep 26;308(12):1221-6. doi: 10.1001/2012.jama.11575.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: October 27, 2010
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 12, 2011

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 10-03-016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO