Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy

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

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.

Condition or disease	Intervention/treatment	Phase
Post-operative Hemorrhage	Drug: Dexamethasone	Not Applicable

Detailed Description:

Detailed description is entered above

Study Design

• 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
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Massachusetts

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary

Investigators

• Principal Investigator: Christopher Hartnick, MD; Massachusetts Eye and Ear Infirmary

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Christopher Hartnick, M.D., Director, Division of Pediatric Otolaryngology, Massachusetts Eye and Ear Infirmary
• ClinicalTrials.gov Identifier: NCT01415583
• Other Study ID Numbers: 10-03-016
• First Posted: August 12, 2011
• 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:

Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage; Pathologic Processes; Intraoperative Complications; Postoperative Complications; Dexamethasone; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents