- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00662987
Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy
April 17, 2008 updated by: Weill Medical College of Cornell University
To determine whether a 3-day course of postoperative antibiotics is effective as a 7-day course in reducing pain and reducing time to resumption of normal diet and activity following pediatric tonsillectomy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
STUDY DESIGN : A prospective, randomized, placebo-controlled trial METHODS : All pediatric patients (under the age of 18) scheduled to undergo a tonsillectomy with or without adenoidectomy from an outpatient otolaryngology practice will be recruited for the study.
Exclusion criteria include prior use of antibiotics 7 days before surgery, penicillin allergy or medical comorbidity necessitating antibiotic use.
Preoperative demographic information will be obtained.
Tonsillectomy with or without adenoidectomy will be performed by a single surgeon (JJ) using electrocautery.
Patients will be randomized to receive either a 3- or 7-day course of amoxicillin.
Parents will be asked to record the following information: analgesic use for the first 7 postoperative days, postoperative days the child initiated her usual diet and level of activity and medical treatment for oral hemorrhage or dehydration.
Statistical analysis will be performed to determine a real difference between the two groups with regard to analgesic use, resumption to normal diet and activity, and incidence of oral hemorrhage or dehydration.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- tonsillectomy with or without adenoidectomy
- under the age of 18
Exclusion Criteria:
- penicillin allergy
- took antibiotics within 7 days of surgery
- medical comorbidity requiring treatment with antibiotics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Group B
Received 3 days of amoxicillin followed by 4 days of placebo
|
3 days of amoxicillin (40 mg/kg divided bid up to maximum daily dose of 800 mg) followed by placebo
|
Active Comparator: Group A
Received 7 days of amoxicillin
|
Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
analgesic use
Time Frame: 1 week
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
time of resumption of normal diet
Time Frame: 1 week
|
1 week
|
time of resumption of normal activity
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jacqueline Jones, MD, Weill Medical College of Cornell University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
April 17, 2008
First Submitted That Met QC Criteria
April 17, 2008
First Posted (Estimate)
April 21, 2008
Study Record Updates
Last Update Posted (Estimate)
April 21, 2008
Last Update Submitted That Met QC Criteria
April 17, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCMC0506007924
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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