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Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

NCT ID: NCT00662987

Last Updated: 2008-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-05-31

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.

Conditions

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Tonsillectomy

Keywords

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tonsillectomy antibiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group B

Received 3 days of amoxicillin followed by 4 days of placebo

Group Type PLACEBO_COMPARATOR

3 days of amoxcillin followed by 4 days of placebo

Intervention Type DRUG

3 days of amoxicillin (40 mg/kg divided bid up to maximum daily dose of 800 mg) followed by placebo

Group A

Received 7 days of amoxicillin

Group Type ACTIVE_COMPARATOR

7 days of amoxicillin

Intervention Type DRUG

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

Interventions

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7 days of amoxicillin

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

Intervention Type 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

Intervention Type DRUG

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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Department of Otorhinolaryngology, Weill Cornell Medical College

Principal Investigators

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Jacqueline Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

References

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Johnson PE, Rickert SM, Jones J. Duration-related efficacy of postoperative antibiotics following pediatric tonsillectomy: a prospective, randomized, placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):984-7. doi: 10.1001/archoto.2009.146.

Reference Type DERIVED
PMID: 19841335 (View on PubMed)

Other Identifiers

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WCMC0506007924

Identifier Type: -

Identifier Source: org_study_id