Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Condition(s) targeted: Tonsillectomy

Intervention: 7 days of amoxicillin (Drug); 3 days of amoxcillin followed by 4 days of placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
Jacqueline Jones, MD, Principal Investigator, Affiliation: Weill Cornell Medical College

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

Official title: Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

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

Primary outcome: analgesic use

Secondary outcome:

time of resumption of normal diet

time of resumption of normal activity

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.

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Weill Cornell Medical College, New York, New York 10021, United States

Starting date: September 2005
Ending date: May 2007
Last updated: April 17, 2008