NCT00662987

Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Tonsillectomy

Interventions

Type	Name	Description
DRUG	7 days of amoxicillin	Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg)
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

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2008-04-21
• Last updated: 2008-04-21

Locations

1 site across 1 country: United States