Role of Antibiotics Post Tonsillectomy

Tonsillectomy Clinical Trial

Official title:

Study Of The Antibiotic Role In Post Tonsillectomy Complications

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03491085
• Other study ID #: Antibiotics with tonsillectomy
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Tonsillectomy

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