Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

NCT01415583 | Completed Results DMC

• 1 other identifier: 10-03-016
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Post-tonsillectomy Bleeding

  2 weeks after surgery

Study Arms (2)

Saline

PLACEBO COMPARATOR

Placebo is described in chart

Drug: Dexamethasone

Dexamethasone

EXPERIMENTAL

Dexamethasone is described in chart

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

0.5mg/kg (max dose 20mg)

Also known as: Decadron

Dexamethasone; Saline

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 23011712 DERIVED

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Christopher Hartnick, Division Director, Pediatric Otolaryngology Director, Pediatric Airway, V
• Organization: Massachusetts Eye and Ear Infirmary

christopher_hartnick@meei.harvard.edu

617-573-4206

Study Officials

• Christopher Hartnick, MD

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Pediatric Otolaryngology

Study Record Dates

• First Submitted: October 27, 2010
• First Posted: August 12, 2011
• Study Start: July 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: July 12, 2017
• Results First Posted: July 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)