Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Tonsillectomy

Treatments: Drug: 3 days of amoxcillin followed by 4 days of placebo; Drug: 7 days of amoxicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT00662987

WCMC0506007924

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Group B

Placebo Comparator group

Description:

Received 3 days of amoxicillin followed by 4 days of placebo

Treatment:

Drug: 3 days of amoxcillin followed by 4 days of placebo

Group A

Active Comparator group

Description:

Received 7 days of amoxicillin

Treatment:

Drug: 7 days of amoxicillin