Role of Antibiotics Post Tonsillectomy

NCT ID: NCT03491085

Last Updated: 2018-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2020-03-15

Brief Summary

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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

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Conditions

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Tonsillectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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tonsillictomy with antibiotics

Group Type ACTIVE_COMPARATOR

Amoxicillin/clavulanate

Intervention Type DRUG

after tonsillectomy half of our patients will receive Amoxicillin /clavulanate for one week and the other half will not receive it.

tonsillictomy Without Antibiotics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Amoxicillin/clavulanate

after tonsillectomy half of our patients will receive Amoxicillin /clavulanate for one week and the other half will not receive it.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Ahmedz

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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ahmed alhussaini, professor

Role: CONTACT

00201220701447

References

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Patel A, Foden N, Rachmanidou A. Is weekend surgery a risk factor for post-tonsillectomy haemorrhage? J Laryngol Otol. 2016 Aug;130(8):763-7. doi: 10.1017/S0022215116008161. Epub 2016 Jun 13.

Reference Type BACKGROUND
PMID: 27292442 (View on PubMed)

Other Identifiers

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Antibiotics with tonsillectomy

Identifier Type: -

Identifier Source: org_study_id

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