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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Placebo Comparator | Received 3 days of amoxicillin followed by 4 days of placebo |
|
| Group A | Active Comparator | Received 7 days of amoxicillin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7 days of amoxicillin | Drug | Received 7 days of amoxicillin (dosed 40mg/kg divided bid up to maximum daily dose of 800 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| analgesic use | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| time of resumption of normal diet | 1 week | |
| time of resumption of normal activity | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Jones, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19841335 | Derived | 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. doi: 10.1001/archoto.2009.146. |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| 3 days of amoxcillin followed by 4 days of placebo | Drug | 3 days of amoxicillin (40 mg/kg divided bid up to maximum daily dose of 800 mg) followed by placebo |
|
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |