Role of Antibiotics Post Tonsillectomy

May 12, 2018 updated by: Fatma Ahmedz, Assiut University

Study Of The Antibiotic Role In Post Tonsillectomy Complications

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 15, 2018

Primary Completion (ANTICIPATED)

January 15, 2020

Study Completion (ANTICIPATED)

March 15, 2020

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

March 31, 2018

First Posted (ACTUAL)

April 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 12, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antibiotics with tonsillectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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