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Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01561703
First Posted: March 23, 2012
Last Update Posted: January 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Missouri-Columbia
  Purpose
This study is designed to look at healthcare utilization following the removal of tonsils and adenoids in pediatric patients who are not given an antibiotic following surgery.

Condition Intervention
Snoring Strep Throat Drug: Antibiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postoperative Healthcare Utilization in Adenotonsillectomy Patients With Postoperative Antibiotic Administration Compared to Patients Without Antibiotic Administration

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Healthcare Utilization [ Time Frame: 6 wks post-operative appointment ]
    Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.


Enrollment: 58
Study Start Date: March 2012
Study Completion Date: June 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anitibiotic
Patients will receive postoperative antibiotic after surgery.
Drug: Antibiotic
One of seven antibiotics (amoxicillin; amoxicillin/clavulanate potassium; azithromycin; cefaclor; cephalexin; cefdinir; or clindamycin) will be given at standard dosage that may be used for 7-10 days following surgery .
Other Names:
  • Amoxicillin
  • Amoxicillin/ and clavulanate potassium/Augmentin
  • Azithromycin/Zithromax
  • Cefaclor/Ceclor
  • Cephalexin
  • Cefdinir/Omnicef
  • Clindamycin/Cleocin Pediatric
No Intervention: Control
Patients will NOT receive postoperative antibiotic

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are candidates for Adenotonsillectomy or Tonsillectomy only (AT/T).
  • Patient age 18 years or younger(if patient not 18 years, then parent/guardian will be the participant and must also meet inclusion criteria #3).
  • English as the primary language.

Exclusion Criteria:

  • Patients not having English as their primary language
  • Patients <18 years of age without a parent/guardian present.
  • Patients with periodic fever syndrome, immunocompromise, hemophilia, cerebral palsy, down syndrome, sickle cell disease, or with known preoperative aspiration.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561703


Locations
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Eliav Gov-Arie, MD University of Missouri-Columbia
  More Information

Publications:
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01561703     History of Changes
Other Study ID Numbers: 1200310
First Submitted: March 16, 2012
First Posted: March 23, 2012
Results First Submitted: October 28, 2015
Results First Posted: January 19, 2017
Last Update Posted: January 19, 2017
Last Verified: November 2016

Keywords provided by University of Missouri-Columbia:
Healthcare utilization
Tonsillectomy
Adenoidectomy/Tonsillectomy
Antibiotics

Additional relevant MeSH terms:
Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Anti-Bacterial Agents
Amoxicillin
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Clavulanic Acid
Clavulanic Acids
Cephalexin
Cefdinir
Cefaclor
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors