Document Detail


The use of perioperative Sofradex eardrops in preventing tympanostomy tube blockage: a prospective double-blinded randomized-controlled trial.
MedLine Citation:
PMID:  15533144     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Around 11-12% of tympanostomy tubes are reported to become blocked by middle ear secretions or blood immediately following surgery, and so no longer function. Many otologists routinely instil an antibiotic and steroid-containing solution at the time of surgery in the belief that this may reduce this complication. The aim of the study was to investigate the efficacy of instilling the antibiotic and steroid-containing solution Sofradex at the time of grommet insertion in preventing grommet blockage. Double-blind randomized-controlled trial, comparing rates of grommet blockage in ears treated with Sofradex drops against control (no drops) in patients undergoing bilateral grommet insertion. Sixty-one pairs of results were obtained. There was a significant difference between the rates of grommet blockage in the two groups. Grommets with Sofradex drops instilled perioperatively were nine times less likely to be blocked than controls [1.6%versus 13.1%, odds ratio (Sofradex/control) = 9.06, 95% confidence interval (CI): 1.04-78.82, P = 0.05]. There was no association between grommet blockage and perioperative bleeding or the nature and presence of middle ear secretions. Sofradex eardrops are effective in reducing the rate of grommet blockage when instilled perioperatively.
Authors:
A K Arya; P A Rea; P J Robinson
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical otolaryngology and allied sciences     Volume:  29     ISSN:  0307-7772     ISO Abbreviation:  Clin Otolaryngol Allied Sci     Publication Date:  2004 Dec 
Date Detail:
Created Date:  2004-11-09     Completed Date:  2005-03-22     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7701793     Medline TA:  Clin Otolaryngol Allied Sci     Country:  England    
Other Details:
Languages:  eng     Pagination:  598-601     Citation Subset:  IM    
Affiliation:
Southmead Hospital, North Bristol NHS Trust, Bristol, UK. arvind7@tesco.net
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Anti-Infective Agents / administration & dosage,  therapeutic use*
Child, Preschool
Dexamethasone / administration & dosage,  therapeutic use*
Double-Blind Method
Drug Combinations
Female
Follow-Up Studies
Framycetin / administration & dosage,  therapeutic use*
Gramicidin / administration & dosage,  therapeutic use*
Humans
Intraoperative Care*
Male
Middle Ear Ventilation / adverse effects*
Postoperative Complications / prevention & control*
Prospective Studies
Chemical
Reg. No./Substance:
0/Anti-Infective Agents; 0/Drug Combinations; 119-04-0/Framycetin; 1405-97-6/Gramicidin; 50-02-2/Dexamethasone; 79173-16-3/Sofradex

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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