Clinical Trial: Ear Drops for Children With Otitis Media

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Ear Drops for Children With Otitis Media

Brief Summary: The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. A total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.

Detailed Summary:
Sponsor: University of Washington

Current Primary Outcome: Resolution of Otitis Media Symptoms [ Time Frame: 5 days ]

Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.


Original Primary Outcome: Resolution of Otitis Media Symptoms [ Time Frame: 5 days ]

Current Secondary Outcome: Side Effects of Therapy [ Time Frame: 5 days ]

Original Secondary Outcome: Same as current

Information By: University of Washington

Dates:
Date Received: February 13, 2008
Date Started: February 2008
Date Completion:
Last Updated: November 4, 2010
Last Verified: November 2010