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

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ClinicalTrials.gov Identifier: NCT01561703
Recruitment Status : Completed
First Posted : March 23, 2012
Results First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
University of Missouri-Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Snoring Strep Throat Drug: Antibiotic Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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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.

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

Publications:
Responsible Party: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01561703     History of Changes
Other Study ID Numbers: 1200310
First Posted: March 23, 2012    Key Record Dates
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