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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Missouri-Columbia.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Eliav Gov-Ari, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01561703
First received: March 16, 2012
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  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
 Other: No postoperative antibiotic
Drug: Amoxicillin
Drug: Amoxicillin/clavulanate potassium
Drug: Azithromycin
Drug: Cefaclor
Drug: Cephalexin
Drug: Cefdinir
Drug: Clindamycin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Healthcare Utilization [ Time Frame: 6 wks post-operative appointment ] [ Designated as safety issue: No ]
    Questionnarie designed to evaluate healthcare utlization following surgery. Unit of measure will be a change in healthcare utilization.
Estimated Enrollment: 58
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Control
Patients will receive postoperative antibiotic after surgery.
 Drug: Amoxicillin
Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .
Drug: Amoxicillin/clavulanate potassium
Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Other Name: Augmentin
Drug: Azithromycin
Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Other Name: Zithromax
Drug: Cefaclor
Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Other Name: Ceclor
Drug: Cephalexin
Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Drug: Cefdinir
Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Other Name: Omnicef
Drug: Clindamycin
Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery
Other Name: Cleocin Pediatric
Experimental: Intervention
Patients will NOT receive postoperative antibiotic
 Other: No postoperative antibiotic
Patients will not be given a prescription for postoperative antibiotics

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   up to 17 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561703

Contacts
Contact: Rebecca Schneider, MS 573-882-2549 schneiderri@health.missouri.edu

Locations
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact: Rebecca I Schneider, MS    573-882-2549    schneiderri@health.missouri.edu   
Principal Investigator: Eliav Gov-Ari, MD         
Sub-Investigator: Jason Showmaker, MD         
Sponsors and Collaborators
University of Missouri-Columbia
  More Information

Publications:

Responsible Party: Eliav Gov-Ari, Assistant Professor, Department of Otolaryngology, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT01561703     History of Changes
Other Study ID Numbers: 1200310 
Study First Received: March 16, 2012
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

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
Amoxicillin-Potassium Clavulanate Combination
Cefdinir
Cefaclor
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Beta-Lactamase Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016