Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

Not Applicable

Completed

• Conditions: Post-operative Hemorrhage
• Interventions: Drug: Dexamethasone

• Registration Number: NCT01415583
• Lead Sponsor: 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.

Detailed Description

Detailed description is entered above

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-10-27
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-12
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2016-12-14
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-12
• Last Update Submitted: 2017-06-12
• Results First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Dexamethasone	Placebo is described in chart
Dexamethasone	Dexamethasone	Dexamethasone is described in chart

Primary Outcome Measures

Name	Time	Method
Number of Participants With Post-tonsillectomy Bleeding	2 weeks after surgery

Trial Locations

Locations (1)

Massachusetts Eye and Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States