| Perioperative dexamethasone administration and risk of bleeding following tonsillectomy in children: a randomized controlled trial. | |
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MedLine Citation:
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PMID: 23011712 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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CONTEXT: Corticosteroids are commonly given to children undergoing tonsillectomy to reduce postoperative nausea and vomiting; however, they might increase the risk of perioperative and postoperative hemorrhage. OBJECTIVE: To determine the effect of dexamethasone on bleeding following tonsillectomy in children. DESIGN, SETTING, AND PATIENTS: A multicenter, prospective, randomized, double-blind, placebo-controlled study at 2 tertiary medical centers of 314 children aged 3 to 18 years undergoing tonsillectomy without a history of bleeding disorder or recent corticosteroid medication use and conducted between July 15, 2010, and December 20, 2011, with 14-day follow-up. We tested the hypothesis that dexamethasone would not result in 5% more bleeding events than placebo using a noninferiority statistical design. INTERVENTION: A single perioperative dose of dexamethasone (0.5 mg/kg; maximum dose, 20 mg), with an equivalent volume of 0.9% saline administered to the placebo group. MAIN OUTCOME MEASURES: Rate and severity of posttonsillectomy hemorrhage in the 14-day postoperative period using a bleeding severity scale (level I, self-reported or parent-reported postoperative bleeding; level II, required inpatient admission for postoperative bleeding; or level III, required reoperation to control postoperative bleeding). RESULTS: One hundred fifty-seven children (median [interquartile range] age, 6 [4-8] years) were randomized into each study group, with 17 patients (10.8%) in the dexamethasone group and 13 patients (8.2%) in the placebo group reporting bleeding events. In an intention-to-treat analysis, the rates of level I bleeding were 7.0% (n = 11) in the dexamethasone group and 4.5% (n = 7) in the placebo group (difference, 2.6%; upper limit 97.5% CI, 7.7%; P for noninferiority = .17); rates of level II bleeding were 1.9% (n = 3) and 3.2% (n = 5), respectively (difference, -1.3%; upper limit 97.5% CI, 2.2%; P for noninferiority < .001); and rates of level III bleeding were 1.9% (n = 3) and 0.6% (n = 1), respectively (difference, 1.3%; upper limit 97.5% CI, 3.8%; P for noninferiority = .002). CONCLUSIONS: Perioperative dexamethasone administered during pediatric tonsillectomy was not associated with excessive, clinically significant level II or III bleeding events based on not having crossed the noninferior threshold of 5%. Increased subjective (level I) bleeding events caused by dexamethasone could not be excluded because the noninferiority threshold was crossed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01415583. |
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Authors:
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Thomas Q Gallagher; Courtney Hill; Shilpa Ojha; Elisabeth Ference; Donald G Keamy; Michael Williams; Maynard Hansen; Rie Maurer; Corey Collins; Jennifer Setlur; Gregory G Capra; Matthew T Brigger; Christopher J Hartnick |
Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: JAMA : the journal of the American Medical Association Volume: 308 ISSN: 1538-3598 ISO Abbreviation: JAMA Publication Date: 2012 Sep |
Date Detail:
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Created Date: 2012-09-26 Completed Date: 2012-09-28 Revised Date: 2013-02-06 |
Medline Journal Info:
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Nlm Unique ID: 7501160 Medline TA: JAMA Country: United States |
Other Details:
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Languages: eng Pagination: 1221-6 Citation Subset: AIM; IM |
Affiliation:
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Department of Otolaryngology, Naval Medical Center Portsmouth, Portsmouth, Virginia, USA. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT01415583 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Antiemetics / adverse effects*, therapeutic use Child Child, Preschool Dexamethasone / adverse effects*, therapeutic use Double-Blind Method Female Humans Male Perioperative Care* Postoperative Hemorrhage / chemically induced* Postoperative Nausea and Vomiting / prevention & control Prospective Studies Risk Severity of Illness Index Tonsillectomy* |
| Chemical | |
Reg. No./Substance:
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0/Antiemetics; 50-02-2/Dexamethasone |
| Comments/Corrections | |
Comment In:
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JAMA. 2013 Feb 6;309(5):437
[PMID:
23385256
]
JAMA. 2013 Feb 6;309(5):437-8 [PMID: 23385257 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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