Determining the effect of different methods of prophylactic antibiotics on complications after adenotonsillectomy
Design
Clinical trial with control group and two intervention groups, parallel group , randomized, phase 2 groups on 58 patients. Sealed envelopes will be used for randomization.
Settings and conduct
The present project will be carried out in Imam Reza and Ghaem Hospitals. It has two intervention groups and a control group. The control group will receive intraoperative cefazolin and postoperative oral amoxicillin. The two intervention groups, once will receive only preoperative injectable cefazolin and the other group will not receive any antibiotics. Patients will be evaluated the day after surgery and one week after, as well as 14 days after surgery.
Participants/Inclusion and exclusion criteria
patients who will refer to Ghaem and Imam Reza Hospital to adenotonsillectomy based on diagnostic studies of obstructive causes and recurrent pharyngitis during the years 1400 to 1401 will be included in the study.
Intervention groups
Two intervention groups, one will receive only preoperative injectable cefazolin and the other group will not receive any antibiotics.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210814052181N1
Registration date:2021-08-30, 1400/06/08
Registration timing:prospective
Last update:2021-08-30, 1400/06/08
Update count:0
Registration date
2021-08-30, 1400/06/08
Registrant information
Name
Javad Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2117
Email address
salimij1400@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of different methods of prophylaxis antibiotics on complications after adenotonsillectomy
Public title
Evaluation of the effect of different methods of prophylaxis antibiotics on complications after adenotonsillectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being 5 to 18 years old
Informed consent
Exclusion criteria:
Take antibiotics 2 weeks before surgery
existence of symptoms of infectious disease before surgery
Allergy to penicillin and cefazolin
The patient has a defective immune system
Age
From 5 years old to 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the method of simple randomization is individual and the randomization tool is a sealed envelope.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Qureshi Building, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-06-19, 1400/03/29
Ethics committee reference number
IR.MUMS.REC.1400.055
Health conditions studied
1
Description of health condition studied
Adenotonsillectomy
ICD-10 code
B34.0
ICD-10 code description
Adenovirus infection, unspecified
Primary outcomes
1
Description
pain
Timepoint
after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Only cefazolin will be given preoperatively
Category
Prevention
2
Description
Intervention group2 : No antibiotics will be prescribed
Category
Other
3
Description
Control group: They will receive injectable cefazolin before surgery and oral amoxicillin after surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital and Ghaem Hospital.
Full name of responsible person
Bashir Rasoulian
Street address
Imam Reza Hospital, Taghiabad Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
Rasoulianb@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Qureshi Building,University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Javad Salimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza Hospital Square, Imam Reza Research and Treatment Center
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
0098513853031
Email
J.salimi.1368@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Javad Salimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza Research and Treatment Center, Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
0098513853031
Email
J.salimi.1368@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Javad Salimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza Research and Treatment Center, Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
0098513853031
Email
J.salimi.1368@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome, is shared.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
Use in review articles
From where data/document is obtainable
By sending an email to the responsible author
What processes are involved for a request to access data/document