Comparison of pain, bleeding, fever and time to return to diet after tonsillectomy between the group who receive antibiotic and who don't
Design
Patients will undergo tonsillectomy and randomly divided in to two groups of control and intervention. Intervention group will get antibiotics (amoxicillin 40 mg/kg) after surgery and control group won't. They will be asked to come 7 days and 2 weeks later to follow up and filling check lists (single blinded). Sample size is 100 . In this study, a randomized block method was used.
Settings and conduct
100 patients with inclusion criteria referring to ENT office in Alzahra hospital, were chosen and after explaining the possible complications of not getting antibiotics they will fill consent forms. Patients will undergo tonsillectomy and randomly divided in to two groups of control and intervention. Intervention group will get antibiotics (amoxicillin 40 mg/kg ) after surgery and control group won't. They will be asked to come 7 days and 2 weeks later to follow up and filling check lists. The trial is one sided blinded and patients are blinded and group allocation was concealed by assigning a unique code to each participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria: common signs of adenotonsillar hypertrophia. Exclusion criteria: sensitivity to antibiotics like penicillin; pharyngitis symptoms; taking antibiotic within 2 weeks before surgery.
Intervention groups
Intervention group: patients who get antibiotic after surgery and control group: patients who don't get antibiotic after surgery.
Main outcome variables
Determination and comparison of pain, bleeding, fever, return time to the main diet after tonsillectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110603006699N4
Registration date:2019-05-28, 1398/03/07
Registration timing:prospective
Last update:2019-05-28, 1398/03/07
Update count:0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Mehrdad Rogha
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3664 0352
Email address
rogha@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-31, 1398/03/10
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of administering oral antibiotics after tonsillectomy on surgery’s complications in patients
Public title
Effect of antibiotic on surgery's complication after tonsillectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with tonsillectomy indications such as: adenotonsillar hypertrophia, OSA, oral breathing, deformity in head and face development, problem in talking, chronic recurrent tonsillitis, chronic middle ear infection or recurrent acute middle ear infection.
Exclusion criteria:
Sensitivity to antibiotics like penicillin
Pharyngitis symptoms
Taking antibiotics within 2 weeks before surgery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be selected according to their referral to the ENT Clinic in this study. Using the random function command of Excell software, random numbers will be assigned to each patient by a person independent of the research team and then he/she prints the numbers on small pieces of paper. Then, the papers will be folded so the page with the numbers could not be seen. After putting the papers into a box, another independent person takes 50 paper pieces from the box and puts them into a section which is known as the Antibiotic group, and the other 50 pieces are put in the section known as the No Antibiotic group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not be informed about the group they are in (control or intervention). Assessors will also be unaware of the patient group. But health care providers, will not be blind due to give Antibiotic to patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical science
Street address
hezar jirib Ave, Isfahan university of medical science
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-05-17, 1396/02/27
Ethics committee reference number
IR.MUI.REC.1396.3.057
Health conditions studied
1
Description of health condition studied
tonsillectomy-antibiotics
ICD-10 code
J35.3
ICD-10 code description
Hypertrophy of tonsils with hypertrophy of adenoids
Primary outcomes
1
Description
The amount of pain after tonsillectomy based on the questionnaire
Timepoint
Measurement of pain 1 and 7 days after tonsillectomy
Method of measurement
visual analogue scale
2
Description
The incidence of post-tonsillectomy hemorrhage based on the questionnaire
Timepoint
Measuring the incidence of bleeding 1 and 7 days after the operation of tonsillectomy
Method of measurement
Designed questionnaire
3
Description
The incidence of post-tonsillectomy fever based on the questionnaire
Timepoint
Measuring the incidence of fever 1 and 7 days after the operation of tonsillectomy
Method of measurement
Designed questionnaire
4
Description
Time to return to regular diet
Timepoint
Measure the time to return to normal diet 14 days after tonsillectomy
Method of measurement
Designed questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: oral amoxicillin is given TDS for one week( 40 mg/kg) (Farabi pharmaceutical company)
Category
Treatment - Drugs
2
Description
Control group: The control group does not receive any antibiotics