Role of Antibiotics Post Tonsillectomy

Phase 1

• Conditions: Tonsillectomy
• Interventions: Drug: Amoxicillin/clavulanate

• Registration Number: NCT03491085
• Lead Sponsor: Assiut University

Brief Summary

morbidity after tonsillictomy remains asignificant problem therefore they recommend prophylactic antibiotics to reduce it.in the other hand, the overuse of antimicrobial agents can lead to antimicrobial resistance ,adverse drug events,and unnecessary cost.so,the effectiveness and necessity of antibiotic following tonsillictomy needs to be studied .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-03-31
• Study First Posted: 2018-04-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-12
• Study Start: 2018-05-15
• Last Update Posted: 2018-05-17
• Primary Completion: 2020-01-15
• Study Completion: 2020-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

200 patients who are scheduled for tonsillectomy with or without adenoidectomy, and their age are less than 18 years old of either gender will be included in our study

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Exclusion Criteria

• 1-Patients age ≥ 18 years.

  2-Trials in which antibiotics was administrated locally or used in the immediate preoperative period (within seven days before surgery).

  3. Medical comorbidity requiring treatment with antibiotics e.g. Rheumatic heart disease

  4-Patients undergoing the following procedures:

  1. Unilateral tonsillectomy or biopsy.
  2. Tonsillectomy for known carcinoma.
  3. Tonsillectomy in conjunction with palatal surgery.
  4. Hot tonsillectomy for tonsillar abscess

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tonsillictomy with antibiotics	Amoxicillin/clavulanate	-

Primary Outcome Measures

Name	Time	Method
compare the morbidity after tonsillectomy between the group which receive antibiotics and the other group which not receive antibiotics	2 years	A questionnaire will be given to the parents on discharge to fill in the type of post-tonsillectomy morbidity of main concern including: fever, secondary bleeding, number of days with throat pain and the number of days to resume normal diet, incidence of abdominal pain, nausea \& vomiting.