Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Tonsillectomy Clinical Trial

Official title:

Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00662987
• Other study ID #: WCMC0506007924
• Status: Completed
• Phase: N/A
• First received: April 17, 2008
• Last updated: April 17, 2008
• Start date: September 2005
• Est. completion date: May 2007

Study information

• Verified date: April 2008
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tonsillectomy

Intervention

Drug:
• 7 days of amoxicillin
Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg)
• 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

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesic use		1 week	No
Secondary	time of resumption of normal diet		1 week	No
Secondary	time of resumption of normal activity		1 week	No