Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Completed

CT.gov ID

NCT00662987

Collaborator

(none)

Enrollment

Location

Arms

19.9

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Tonsillectomy	Drug: 7 days of amoxicillin Drug: 3 days of amoxcillin followed by 4 days of placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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)

Arm

Intervention/Treatment

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)

Outcome Measures

Primary Outcome Measures

analgesic use [1 week]

Secondary Outcome Measures

time of resumption of normal diet [1 week]
time of resumption of normal activity [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00662987

Other Study ID Numbers:

WCMC0506007924

First Posted:

Apr 21, 2008

Last Update Posted:

Apr 21, 2008

Last Verified:

Apr 1, 2008

Keywords provided by , ,

tonsillectomy

antibiotics

Additional relevant MeSH terms:

Amoxicillin

Study Results

No Results Posted as of Apr 21, 2008