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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Snoring Strep Throat | Drug: Antibiotic | Not Applicable |

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 |

Arm | Intervention/treatment |
---|---|
Experimental: Anitibiotic
Patients will receive postoperative antibiotic after surgery.
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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:
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No Intervention: Control
Patients will NOT receive postoperative antibiotic
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- 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 |
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.

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
United States, Missouri | |
University of Missouri | |
Columbia, Missouri, United States, 65212 |
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 |