Comparison of changes in nasal congestion after Lefort surgery using Nasonex nasal spray and phenylephrine
Design
This study will be conducted as a double-blind randomized controlled clinical trial. Patients will be randomly divided into two intervention groups (Mometasone Nasonex = Mometasone Furoate 0.05%, Organon) and control (Phenylephrine Nasophrin 0.5% = Siandaru-Tehran, Iran). A computer-generated random sequence will be used to ensure true randomization for the distribution of sprays. After surgery, each drug will be sprayed three times a day for 3 days in both sinuses at the rate of one puff. The instrument of this study is the standard Snot 20 (Sino-Nasal Outcome Test) questionnaire. This questionnaire will be given to the patient on the third and tenth day after surgery.
Settings and conduct
The study will be conducted as a randomized, double-blind, controlled clinical trial. Neither the participants, nor the healthcare providers prescribing the nasal sprays, nor the outcome assessors will be aware of the treatment outcomes. The nasal sprays will be prepared by a third-party pharmacist who will not be involved in the study and distributed with identical labeling and ensuring that both sprays are identical in appearance, odor, and packaging. The study will be conducted at velayat Mashhad Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: maxillary orthognathic surgery; absence of sinus and allergic disease; absence of craniofacial syndromes and cleft lip and palate, and absence of sinus medication. Exclusion criteria: occurrence of complications and intraoperative incidents.
Intervention groups
Patients will be randomly divided into two intervention groups (Mometasone furoate 0.05%, Organon) and control (Phenylephrine 0.5%, Siandaru-Tehran, Iran).
Main outcome variables
Average score of the standard SNOT 20 questionnaire between the intervention and observation groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180312039060N5
Registration date:2024-12-28, 1403/10/08
Registration timing:prospective
Last update:2024-12-28, 1403/10/08
Update count:0
Registration date
2024-12-28, 1403/10/08
Registrant information
Name
Alireza Ebrahimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4326 0653
Email address
alireza.ebrahimpour.1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of nasal congestion difference post lefort surgery using mometasone furoate vs phenylephrine nasal spray
Public title
Comparison of nasal congestion difference post lefort surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Maxillary orthognathic surgery
Absence of sinus and allergic disease
Absence of craniofacial syndromes and cleft lip and palate
Absence of sinus medication
Exclusion criteria:
Patient's unwillingness to participate in the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups: intervention (nasonex = mometasone furoate 0.05%, Organon) and control (nasophrin 0.5% = Siandaru-Tehran, Iran). A computer-generated random sequence will be used to ensure true randomization for the distribution of sprays.
Blinding (investigator's opinion)
Double blinded
Blinding description
The nasal sprays will be prepared by a third-party pharmacist who will not be involved in the study and distributed with identical labeling, ensuring that both sprays are identical in appearance, odor, and packaging.
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
Mashhad University of Medical Sciences, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
123456789
Approval date
2024-11-05, 1403/08/15
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1403.142
Health conditions studied
1
Description of health condition studied
Nasal congestion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Average score of the standard SNOT 20 (sino-nasal outcome test) questionnaire
Timepoint
On the third and tenth day after surgery
Method of measurement
The standard SNOT 20 (sino-nasal outcome test) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients will be randomly assigned to the intervention group (Mometasone Nasonex = Mometasone Furoate 0.05%, Organon). After surgery, each drug will be sprayed three times a day for 3 days in both sinuses, one puff.
Category
Treatment - Drugs
2
Description
Control group: Patients will be randomly assigned to the Control group(Phenylephrine nasophrin 0.5% = siandaru-tehran,iran) . After surgery, each drug will be sprayed three times a day for 3 days in both sinuses, one puff.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Alireza Ebrahimpour
Street address
Velayat Hospital, intersection of Namaz Boulevard and Shahid Kaveh Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 51 3804 2000
Email
Alireza.ebrahimpour.1996@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohsen tafaghodi
Street address
Mashhad, Azadi Square, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 51 8670 5503
Email
tafaghodm1398@mums.ac.ir
Web page address
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
Alireza Ebrahimpour
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 11 4326 0653
Fax
Email
alireza.ebrahimpour.1996@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ebrahimpour
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 11 4326 0653
Fax
Email
alireza.ebrahimpour.1996@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ebrahimpour
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177890001
Phone
+98 11 4326 0653
Fax
Email
alireza.ebrahimpour.1996@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available