Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Conditions
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Tonsillectomy

Intervention / Treatment
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* Drug: 7 days of amoxicillin
* Drug: 3 days of amoxcillin followed by 4 days of placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group B<br>Received 3 days of amoxicillin followed by 4 days of placebo | Drug: 3 days of amoxcillin followed by 4 days of placebo<br>* 3 days of amoxicillin (40 mg/kg divided bid up to maximum daily dose of 800 mg) followed by placebo<br>|
| Active Comparator: Group A<br>Received 7 days of amoxicillin | Drug: 7 days of amoxicillin<br>* Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic use |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of resumption of normal diet |  | 1 week | 
| time of resumption of normal activity |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tonsillectomy, antibiotics