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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03491085
Other study ID # Antibiotics with tonsillectomy
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 15, 2018
Est. completion date March 15, 2020

Study information

Verified date May 2018
Source Assiut University
Contact ahmed alhussaini, professor
Phone 00201220701447
Email alhussainiahmad@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date March 15, 2020
Est. primary completion date January 15, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary compare the morbidity after tonsillectomy between the group which receive antibiotics and the other group which not receive antibiotics 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
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