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Trial record 2 of 14 for:    Reduce-It

Role of Antibiotics Post Tonsillectomy

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ClinicalTrials.gov Identifier: NCT03491085
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Fatma Ahmedz, 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 .

Condition or disease Intervention/treatment Phase
Role of Antibiotic After Tonsillectomy Drug: Amoxicillin/clavulanate Phase 1 Phase 2

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
U.S. FDA Resources

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03491085


Contacts
Contact: ahmed alhussaini, professor 00201220701447 alhussainiahmad@aun.edu.eg

Sponsors and Collaborators
Assiut University

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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anti-Bacterial Agents
Amoxicillin
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