Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Not Applicable

Completed

• Conditions: Tonsillectomy
• Interventions: Drug: 3 days of amoxcillin followed by 4 days of placebo; Drug: 7 days of amoxicillin

• Registration Number: NCT00662987
• Lead Sponsor: Weill Medical College of Cornell University

Brief 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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2008-04
• Study First Submitted: 2008-04-17
• Study First Submitted QC: 2008-04-17
• Last Update Submitted: 2008-04-17
• Study First Posted: 2008-04-21
• Last Update Posted: 2008-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	3 days of amoxcillin followed by 4 days of placebo	Received 3 days of amoxicillin followed by 4 days of placebo
Group A	7 days of amoxicillin	Received 7 days of amoxicillin

Primary Outcome Measures

Name	Time	Method
analgesic use	1 week

Secondary Outcome Measures

Name	Time	Method
time of resumption of normal diet	1 week
time of resumption of normal activity	1 week

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States