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Role of Antibiotics Post Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03491085
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : May 17, 2018
Information provided by (Responsible Party):
Fatma Ahmedz, Assiut University

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

Condition or disease Intervention/treatment Phase
Tonsillectomy Drug: Amoxicillin/clavulanate Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Study Of The Antibiotic Role In Post Tonsillectomy Complications
Estimated Study Start Date : May 15, 2018
Estimated Primary Completion Date : January 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Amoxicillin

Arm Intervention/treatment
Active Comparator: tonsillictomy with antibiotics Drug: Amoxicillin/clavulanate
after tonsillectomy half of our patients will receive Amoxicillin /clavulanate for one week and the other half will not receive it.

No Intervention: tonsillictomy Without Antibiotics

Primary Outcome Measures :
  1. compare the morbidity after tonsillectomy between the group which receive antibiotics and the other group which not receive antibiotics [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03491085

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Contact: ahmed alhussaini, professor 00201220701447

Sponsors and Collaborators
Assiut University

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Responsible Party: Fatma Ahmedz, principal investigator, Assiut University Identifier: NCT03491085    
Other Study ID Numbers: Antibiotics with tonsillectomy
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action