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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Snoring
Strep Throat
Intervention Drug: Antibiotic
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description

Patients will receive postoperative antibiotic after surgery.

Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .

Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Patients will NOT receive postoperative antibiotic

No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics

Period Title: Overall Study
Started 28 30
Completed 20 24
Not Completed 8 6
Arm/Group Title Intervention Control Total
Hide Arm/Group Description

Patients will receive postoperative antibiotic after surgery.

Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .

Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Patients will NOT receive postoperative antibiotic

No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics

Total of all reporting groups
Overall Number of Baseline Participants 20 24 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
<18 years Number Analyzed 20 participants 24 participants 44 participants
20 24 44
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 24 participants 44 participants
Female
6
  30.0%
12
  50.0%
18
  40.9%
Male
14
  70.0%
12
  50.0%
26
  59.1%
1.Primary Outcome
Title Healthcare Utilization
Hide Description Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.
Time Frame 6 wks post-operative appointment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Patients will receive postoperative antibiotic after surgery.

Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .

Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Patients will NOT receive postoperative antibiotic

No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics

Overall Number of Participants Analyzed 20 24
Measure Type: Number
Unit of Measure: participants
Reported Fever 5 16
Made a phone call to clinic 5 8
ER/UR/Clinic visit 2 9
Received "additional" antibiotic 0 6
Diagnostic workup at ER 0 6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description

Patients will receive postoperative antibiotic after surgery.

Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .

Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery

Patients will NOT receive postoperative antibiotic

No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics

All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/24 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Research Coordinator
Organization: University of Missouri - Department of Otolaryngology - Head and Neck Surgery
Phone: 5738822549
EMail: schneiderri@health.missouri.edu
Layout table for additonal information
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