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Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

Primary Purpose

Post-operative Hemorrhage

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

About this trial

This is an interventional treatment trial for Post-operative Hemorrhage

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline

Dexamethasone

Arm Description

Placebo is described in chart

Dexamethasone is described in chart

Outcomes

Primary Outcome Measures

Number of Participants With Post-tonsillectomy Bleeding

Secondary Outcome Measures

Full Information

NCT ID

NCT01415583

First Posted

October 27, 2010

Last Updated

June 12, 2017

Sponsor

Massachusetts Eye and Ear Infirmary

1. Study Identification

Unique Protocol Identification Number

NCT01415583

Brief Title

Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

Official Title

Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

July 2010 (Actual)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts Eye and Ear Infirmary

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-operative Hemorrhage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

314 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

Placebo is described in chart

Arm Title

Dexamethasone

Arm Type

Experimental

Arm Description

Dexamethasone is described in chart

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron

Intervention Description

0.5mg/kg (max dose 20mg)

Primary Outcome Measure Information:

Title

Number of Participants With Post-tonsillectomy Bleeding

Time Frame

2 weeks after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Hartnick, MD

Organizational Affiliation

Massachusetts Eye and Ear Infirmary

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts Eye and Ear Infirmary

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23011712

Citation

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.

Results Reference

derived

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Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

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