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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Snoring; Strep Throat	Drug: Antibiotic	Not Applicable

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	March 23, 2012
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