Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy - Full Text View

Sponsor:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00662987

Purpose

To determine whether a 3-day course of postoperative antibiotics is effective as a 7-day course in reducing pain and reducing time to resumption of normal diet and activity following pediatric tonsillectomy

Condition	Intervention
Tonsillectomy	Drug: 7 days of amoxicillin Drug: 3 days of amoxcillin followed by 4 days of placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Tonsils and Adenoids

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

analgesic use [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time of resumption of normal diet [ Time Frame: 1 week ] [ Designated as safety issue: No ]
time of resumption of normal activity [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	September 2005
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Group B Received 3 days of amoxicillin followed by 4 days of placebo	Drug: 3 days of amoxcillin followed by 4 days of placebo 3 days of amoxicillin (40 mg/kg divided bid up to maximum daily dose of 800 mg) followed by placebo
Active Comparator: Group A Received 7 days of amoxicillin	Drug: 7 days of amoxicillin Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg)

Detailed Description:

STUDY DESIGN : A prospective, randomized, placebo-controlled trial METHODS : All pediatric patients (under the age of 18) scheduled to undergo a tonsillectomy with or without adenoidectomy from an outpatient otolaryngology practice will be recruited for the study. Exclusion criteria include prior use of antibiotics 7 days before surgery, penicillin allergy or medical comorbidity necessitating antibiotic use. Preoperative demographic information will be obtained. Tonsillectomy with or without adenoidectomy will be performed by a single surgeon (JJ) using electrocautery. Patients will be randomized to receive either a 3- or 7-day course of amoxicillin. Parents will be asked to record the following information: analgesic use for the first 7 postoperative days, postoperative days the child initiated her usual diet and level of activity and medical treatment for oral hemorrhage or dehydration. Statistical analysis will be performed to determine a real difference between the two groups with regard to analgesic use, resumption to normal diet and activity, and incidence of oral hemorrhage or dehydration.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

tonsillectomy with or without adenoidectomy
under the age of 18

Exclusion Criteria:

penicillin allergy
took antibiotics within 7 days of surgery
medical comorbidity requiring treatment with antibiotics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662987

Locations

United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

Jacqueline Jones, MD

Weill Medical College of Cornell University

More Information

No publications provided by Weill Medical College of Cornell University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Johnson PE, Rickert SM, Jones J. Duration-related efficacy of postoperative antibiotics following pediatric tonsillectomy: a prospective, randomized, placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):984-7.

Responsible Party:	Jacqueline Jones, MD, Department of Otorhinolaryngology, Weill Cornell Medical College
ClinicalTrials.gov Identifier:	NCT00662987 History of Changes
Other Study ID Numbers:	WCMC0506007924
Study First Received:	April 17, 2008
Last Updated:	April 17, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

tonsillectomy
antibiotics

Additional relevant MeSH terms:

Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 07, 2012