Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use - Full Text View

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	Drug: Antibiotic


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

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 ]
Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.


Enrollment:	58
Study Start Date:	March 2012
Study Completion Date:	June 2015
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Show Detailed Description

Eligibility


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.

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

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

More Information

Publications:

Telian SA, Handler SD, Fleisher GR, Baranak CC, Wetmore RF, Potsic WP. The effect of antibiotic therapy on recovery after tonsillectomy in children. A controlled study. Arch Otolaryngol Head Neck Surg. 1986 Jun;112(6):610-5.

Colreavy MP, Nanan D, Benamer M, Donnelly M, Blaney AW, O'Dwyer TP, Cafferkey M. Antibiotic prophylaxis post-tonsillectomy: is it of benefit? Int J Pediatr Otorhinolaryngol. 1999 Oct 15;50(1):15-22.

Krishna P, LaPage MJ, Hughes LF, Lin SY. Current practice patterns in tonsillectomy and perioperative care. Int J Pediatr Otorhinolaryngol. 2004 Jun;68(6):779-84.

Baugh RF, Archer SM, Mitchell RB, Rosenfeld RM, Amin R, Burns JJ, Darrow DH, Giordano T, Litman RS, Li KK, Mannix ME, Schwartz RH, Setzen G, Wald ER, Wall E, Sandberg G, Patel MM; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011 Jan;144(1 Suppl):S1-30. doi: 10.1177/0194599810389949.


Responsible Party:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT01561703 History of Changes
Other Study ID Numbers:	1200310
Study First Received:	March 16, 2012
Results First Received:	October 28, 2015
Last Updated:	November 22, 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

ClinicalTrials.gov processed this record on September 21, 2017