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

NCT01561703 | Completed Results

• 1 other identifier: 1200310
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Snoring; Strep Throat

Keywords

Healthcare utilization; Tonsillectomy; Adenoidectomy/Tonsillectomy; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Healthcare Utilization

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

  6 wks post-operative appointment

Study Arms (2)

Anitibiotic

EXPERIMENTAL

Patients will receive postoperative antibiotic after surgery.

Drug: Antibiotic

Control

NO INTERVENTION

Patients will NOT receive postoperative antibiotic

Interventions

Antibiotic DRUG

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 .

Also known as: Amoxicillin, Amoxicillin/ and clavulanate potassium/Augmentin, Azithromycin/Zithromax, Cefaclor/Ceclor, Cephalexin, Cefdinir/Omnicef, Clindamycin/Cleocin Pediatric

Anitibiotic

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients who are candidates for Adenotonsillectomy or Tonsillectomy only (AT/T).
• English as the primary language.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (4)

• 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. doi: 10.1001/archotol.1986.03780060022002.

  PMID: 3516177 BACKGROUND

• 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. doi: 10.1016/s0165-5876(99)00228-1.

  PMID: 10596882 BACKGROUND

• 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. doi: 10.1016/j.ijporl.2004.01.010.

  PMID: 15126019 BACKGROUND

• 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.

  PMID: 21493257 BACKGROUND

MeSH Terms

Conditions

Snoring

Interventions

Anti-Bacterial Agents; Amoxicillin; Clavulanic Acid; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Cefaclor; Cephalexin; Cefdinir; Clindamycin

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acids; Drug Combinations; Pharmaceutical Preparations; Erythromycin; Macrolides; Polyketides; Lactones; Cephalosporins; Thiazines; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Results Point of Contact

• Title: Research Coordinator
• Organization: University of Missouri - Department of Otolaryngology - Head and Neck Surgery

schneiderri@health.missouri.edu

5738822549

Study Officials

• Eliav Gov-Arie, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 23, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2015
• Last Updated: January 19, 2017
• Results First Posted: January 19, 2017

Record last verified: 2016-11

Locations

US (1)