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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 is entered above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | Placebo is described in chart |
|
| Dexamethasone | Experimental | Dexamethasone is described in chart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 0.5mg/kg (max dose 20mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Post-tonsillectomy Bleeding | 2 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Hartnick, MD | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23011712 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saline | Dexamethasone: 0.5mg/kg (max dose 20mg) |
| FG001 | Dexamethasone | Dexamethasone: 0.5mg/kg (max dose 20mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline | Dexamethasone: 0.5mg/kg (max dose 20mg) |
| BG001 | Dexamethasone | Dexamethasone: 0.5mg/kg (max dose 20mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Post-tonsillectomy Bleeding | Posted | Number | 97.5% Confidence Interval | participants | 2 weeks after surgery |
|
|
6 months
Subjects were instructed to inform study staff of any adverse events occurring during the 2 week post-operative period and during any follow-up visits 6 months post surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Saline | Dexamethasone: 0.5mg/kg (max dose 20mg) | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Hartnick, Division Director, Pediatric Otolaryngology Director, Pediatric Airway, V | Massachusetts Eye and Ear Infirmary | 617-573-4206 | christopher_hartnick@meei.harvard.edu |
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| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 157 |
| 0 |
| 157 |
| 0 |
| 157 |
| EG001 | Dexamethasone | Dexamethasone: 0.5mg/kg (max dose 20mg) | 0 | 157 | 0 | 157 | 0 | 157 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |