Efficacy of Intranasal Corticosteroid (Fluticasone) on Adenotonsillar Hypertrophy
Design
The study with before & after plan after two weeks of using Nasal Fluticasone
Settings and conduct
Children aged 4 to 10 years with adenotonsillar hypertrophy referred to the clinic of Shohada Gomnam Hospital in Yazd Who have been taking inhaled Fluticasone for two weeks and are being re-examined. How to use the spray was explained in the previous sections.
Participants/Inclusion and exclusion criteria
Children aged 4 to 10 years with adenotonsillar hypertrophy who participate in the study with satisfaction. Symptoms of snoring, rhinorrhea, nasal congestion, and enlarged tonsils in the clinical examination are the conditions for inclusion in the study.
Non-entry conditions include anatomical abnormalities, neuromuscular disease, upper respiratory tract infection, allergic rhinitis, recurrent tonsillitis.
Intervention groups
Nasal Fluticasone spray is applied to each nostril every 12 hours for two weeks. No side effects. We do not have a control group.
Main outcome variables
Symptoms of adenotonsillar hypertrophy include rhinorrhea, snoring, nasal congestion, and enlarged tonsils on clinical examination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210228050524N1
Registration date:2021-05-08, 1400/02/18
Registration timing:retrospective
Last update:2021-05-08, 1400/02/18
Update count:0
Registration date
2021-05-08, 1400/02/18
Registrant information
Name
Hamed Hatefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3138 0015
Email address
drh_hatefi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-17, 1399/12/27
Expected recruitment end date
2021-04-30, 1400/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Intranasal Corticosteroid (Fluticasone) on Adenotonsillar Hypertrophy
Public title
Efficacy of Intranasal Corticosteroid (Fluticasone) on Adenotonsillar Hypertrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 4 to 10 Years Old With Adenotonsillar Hypertrophy
Existence Of Snoring
Existence Of Enlarged tonsils in clinical examination
Existence Of Nasal congestion
Existence Of Rhinorrhea
Exclusion criteria:
Existence Of Anatomical Abnormalities
Existence Of Neuromuscular Disease
Existence Of Upper Respiratory Tract Infections
Existence Of Allergic Rhinitis
Existence Of Recurrent Tonsillitis
Age
From 4 years old to 10 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The ENT specialist will give the medicine to the patient for two weeks after the evaluation. The evaluator is not aware of the symptoms before or after treatment. And examines the evaluated questionnaire to understand the result
Placebo
Not used
Assignment
Single
Other design features
A group with a before & after plan . The drug is routine and has been used before and has no side effects
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical Sciences
Street address
Ali Ibn Abitaleb Medical School, Islamic Azad University Of yazd, Shohada Gomnam Boulevard, Safaeieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877318
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.IAU.Yazd.REC.1399.066
Health conditions studied
1
Description of health condition studied
Efficacy of Intranasal Corticosteroid (Fluticasone) on Adenotonsillar Hypertrophy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Adenotonsillar Hypertrophy in clinical examination and symptoms of nasal congestion, snoring, rhinorrhea
Timepoint
Two Weeks
Method of measurement
Clinically and according to the opinion of the ENT Specialist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, patients aged 4 to 10 years with the described symptoms are analyzed. They take Fluticasone nasal spray for two weeks. We do not have a control group .According to an ENT specialist, patients under the age of 12 should use puff every 12 hours on each side of the nose. Each puff contains 50 micrograms. The price of both Iranian and foreign types was the same. We did not require the patient to use the Iranian or foreign type or the specific type of company. Iranian type that was mostly available in the market was from Sina Daroo Company and 20 ml in a plastic spray pump. The drug is a white suspension. It should be shaken before consumption. Insert the spray head into one of the nostrils and manually block the other nostril. While breathing through the nose and with the mouth closed, push the spray all the way in while inhaling. If they miss a dose, they can take it immediately, but if it is time for the next dose, there is no need to take a missed dose or double the next dose .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Of Shohada Kargar Hospital In Yazd
Full name of responsible person
Dr Hamed Hatefi. ENT Specialist
Street address
Shohada Kargar Hospital, Modarres Boulevard, Yazd
City
Yazd
Province
Yazd
Postal code
1457965595
Phone
+98 35 3182 2000
Fax
+98 35 3825 0007
Email
shohadakargar.hos@tamin.ir
Web page address
https://shohadakargar.tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Seyed Mohammad Reza Mortazavizadeh
Street address
Research Unit, Ali Ibn Abitaleb Medical School, Islamic Azad University of Yazd, Shohada Gomnam boulevard, Safaeieh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877318
Phone
+98 35 3821 0540
Email
mortazavizadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr Hamed Hatefi
Position
ENT Subspecialty
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Yazd: Shahid Pakenjad Boulevard, after Moallem Square, next to Bahareh Hotel, at the beginning of Javad Al-Aimeh Alley
City
Yazd
Province
Yazd
Postal code
8915785729
Phone
+98 35 3138 0015
Email
drh_hatefi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Hamed Hatefi
Position
ENT Subspecialty
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
at the begining if Javad Al-Aiemeh Alley, next to Bahareh Hotel, after Moallem Square, Shahid Paknejad Boulevard, Yazd