Role of Antibiotics Post Tonsillectomy
Study Of The Antibiotic Role In Post Tonsillectomy Complications
1 other identifier
interventional
200
0 countries
N/A
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2018
CompletedFirst Posted
Study publicly available on registry
April 9, 2018
CompletedStudy Start
First participant enrolled
May 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2020
CompletedMay 17, 2018
May 1, 2018
1.7 years
March 16, 2018
May 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
tonsillictomy with antibiotics
ACTIVE COMPARATORtonsillictomy Without Antibiotics
NO INTERVENTIONInterventions
after tonsillectomy half of our patients will receive Amoxicillin /clavulanate for one week and the other half will not receive it.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients age ≥ 18 years.
- Trials in which antibiotics was administrated locally or used in the immediate preoperative period (within seven days before surgery).
- \. Medical comorbidity requiring treatment with antibiotics e.g. Rheumatic heart disease
- Patients undergoing the following procedures:
- Unilateral tonsillectomy or biopsy.
- Tonsillectomy for known carcinoma.
- Tonsillectomy in conjunction with palatal surgery.
- Hot tonsillectomy for tonsillar abscess
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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.
PMID: 27292442BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
March 16, 2018
First Posted
April 9, 2018
Study Start
May 15, 2018
Primary Completion
January 15, 2020
Study Completion
March 15, 2020
Last Updated
May 17, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share