Tonsillectomy
Conditions
Keywords
tonsillectomy, antibiotics
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
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.
Interventions
DRUG7 days of amoxicillin
Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg)
DRUG3 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
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| analgesic use | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| time of resumption of normal diet | 1 week |
| time of resumption of normal activity | 1 week |
Countries
United States
Outcome results
None listed