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Completed

NCT Number: NCT00662987

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

Completed

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Key information

Conditions

Tonsillectomy

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical College

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7 days of amoxicillin

Drug

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

3 days of amoxcillin followed by 4 days of placebo

Drug

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

Primary outcomes

  1. analgesic use

    Time frame: 1 week

Secondary outcomes

  1. time of resumption of normal diet

    Time frame: 1 week

  2. time of resumption of normal activity

    Time frame: 1 week

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 21, 2008
Registry last updated
Apr 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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