Official Title: “Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy”

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 Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2007

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Group B
  • Received 3 days of amoxicillin followed by 4 days of placebo
• Active Comparator: Group A
  • Received 7 days of amoxicillin

Primary Measures

• analgesic use
  • Time Frame: 1 week
    Safety Issue?: No

Secondary Measures

• time of resumption of normal diet
  • Time Frame: 1 week
    Safety Issue?: No
• time of resumption of normal activity
  • Time Frame: 1 week
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Weill Medical College of Cornell University

Overall Clinical Trial Officials and Contacts

Jacqueline Jones, MD Principal Investigator Weill Cornell Medical College  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00662987

Study ID Number: WCMC0506007924

ClinicalTrials.gov Identifier: NCT00662987

Health Authority: United States: Institutional Review Board