Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use
This study is currently recruiting participants.
Verified March 2012 by University of Missouri-Columbia
Sponsor:
University of Missouri-Columbia
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
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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:
Drug Information available for:
Potassium bicarbonate
Potassium chloride
Cephalexin
Clindamycin hydrochloride
Clindamycin phosphate
Clindamycin palmitate hydrochloride
Amoxicillin
Amoxicillin sodium
Clindamycin palmitate
Cefaclor
Clavulanate potassium
Azithromycin
Cefdinir
Cephalexin hydrochloride
Azithromycin dihydrate
Azithromycin monohydrate
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 |
| 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
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:
|
Anti-Bacterial Agents Snoring Respiratory Sounds Signs and Symptoms, Respiratory Signs and Symptoms Amoxicillin Cefaclor Cephalexin Clindamycin Clindamycin-2-phosphate Azithromycin |
Amoxicillin-Potassium Clavulanate Combination Clavulanic Acids Clavulanic Acid Cefdinir Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013