Background: adenoidal hypertrophy is a common condition of childhood, when obstructive sleep apnea occurs adenoidectomy is indicated. In less severe cases, non surgical interventions maybe considered, however few medical alternatives are currently available. Intranasal steroids has used to reduce nasal airway obstruction
Objectives:to assess the effectiveness of intranasal corticosteroids for improving nasal airway obstruction in children with adenoid hypertrophy.
Materials and methods: 77 children 1-12 years exhibiting adenoid hypertrophy symptom and confirmed with radiologic imaging and without tonsil hypertrophy who were not inclined to surgery were included and divided to two groups. One group was treated with intranasal betamethasone 3 times daily for 3 weeks and the second group was treated with intranasal NaCl solution as placebo. The subjects were assessed for airway obstruction symptoms including, snoring breathing and rhinore, via questionnaire ear examination, first month and third month of treatment.
Inclusion criteria: all of the infant 1-12 years with symptomatic adenoid hypertrophy without emergency indication surgery.
Exclusion criteria: hypertrophy of adenoid with tonsil hypertrophy and indication emergency surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051813366N1
Registration date:2013-06-15, 1392/03/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-15, 1392/03/25
Registrant information
Name
Parsa Yousefi Chaijan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1964
Email address
dr.yousefi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2013-07-06, 1392/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intranasal corticosteroids on nasal airway obstruction, behavioral and neurocognitive dysfunction in children with adenoidal hypertrophy
Public title
The effect of intranasal corticosteroids on nasal airway obstruction, behavioral and neurocognitive dysfunction in children with adenoidal hypertrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all of the infant 1-12 years with symptomatic adenoid hypertrophy without emergency indication surgery.
Exclusion criteria: hypertrophy of adenoid with tonsil hypertrophy and indication emergency surgery.
Age
From 1 year old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
77
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences Ethics Committee
Street address
Near Amiralmomenin hosptial, Sardasht, Arak
City
Arak
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
91-128-2
Health conditions studied
1
Description of health condition studied
Adenoid hypertrophy with snoring and nasal congestion
ICD-10 code
J35
ICD-10 code description
Hypertrophy of adenoids
Primary outcomes
1
Description
snoring
Timepoint
1 , 3 month after treatment
Method of measurement
history and physical examination
2
Description
change of facial bone
Timepoint
1 , 3 month after treatment
Method of measurement
history and physical examination
3
Description
mouth breath
Timepoint
1 , 3 month after treatment
Method of measurement
history and physical examination
4
Description
rhinorea
Timepoint
1 , 3 month after treatment
Method of measurement
history and physical examination
Secondary outcomes
1
Description
Local and systemic compliction of bethamethason
Timepoint
One month after of intervention – 3 month after intervention
Method of measurement
Questionnaire sheet with clinical symptome
Intervention groups
1
Description
in the case group betametason drop TDS two drop used in the nasal cavity and evaluation 1 to 3 Interval according obstractive and infectious symptome
Category
Treatment - Drugs
2
Description
in the control group N/S drop TDS two drop used in the nasal cavity and evaluation 1 to 3 Interval according obstractive and infectious symptome
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpo
Street address
Near Amiralmomenin hosptial, Sardasht, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Farzad Zamani Barsari
Position
Assistant professor
Other areas of specialty/work
Street address
Amirkabir hospital, Arak
City
Arak
Postal code
Phone
+98 86 1312 4677
Fax
Email
farzamani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
arak university of medical sciences
Full name of responsible person
parsa yousefichaijan
Position
assistant professor
Other areas of specialty/work
Street address
hospiatal amirkabir alamolhoda Arak
City
Arak
Postal code
Phone
+98 86 1312 4677
Fax
Email
parsayousefichaijan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)