Effect of Duration of Antibiotic Therapy on Recovery Following Tonsillectomy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- analgesic use
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- 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
Arms & Interventions
Group B
Received 3 days of amoxicillin followed by 4 days of placebo
Intervention: 3 days of amoxcillin followed by 4 days of placebo (Drug)
Group A
Received 7 days of amoxicillin
Intervention: 7 days of amoxicillin (Drug)
Outcomes
Primary Outcomes
analgesic use
Time Frame: 1 week
Secondary Outcomes
- time of resumption of normal diet(1 week)
- time of resumption of normal activity(1 week)