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| Sponsored by: |
Weill Medical College of Cornell University |
|---|---|
| Information provided by: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00662987 |
Purpose
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
| Condition | Intervention |
|---|---|
|
Tonsillectomy |
Drug: 7 days of amoxicillin Drug: 3 days of amoxcillin followed by 4 days of placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy |
| Enrollment: | 50 |
| Study Start Date: | September 2005 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group B: Placebo Comparator
Received 3 days of amoxicillin followed by 4 days of placebo
|
Drug: 3 days of amoxcillin 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
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Group A: Active Comparator
Received 7 days of amoxicillin
|
Drug: 7 days of amoxicillin
Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg)
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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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Jacqueline Jones, MD | Weill Cornell Medical College |
More Information
| Responsible Party: | Department of Otorhinolaryngology, Weill Cornell Medical College ( Jacqueline Jones, MD ) |
| Study ID Numbers: | WCMC0506007924 |
| Study First Received: | April 17, 2008 |
| Last Updated: | April 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00662987 |
| Health Authority: | United States: Institutional Review Board |
|
tonsillectomy antibiotics |
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Amoxicillin |
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Anti-Infective Agents Anti-Bacterial Agents Therapeutic Uses Pharmacologic Actions |
