Evaluating the amount of pain after administration of a single dose of 10mg montelukast tablet one hour before the bimaxillary orthognathic surgery
Design
A clinical trial with a control group, with parallel groups, triple blinded, randomized, phase 3 on 60 patients. The patient, surgeon, outcome assessor, and statistical analyzer will not be aware of the study groups.
Block randomization will be done by the computer software "Random Allocation Software".
Settings and conduct
ُSetting: Maxillofacial department of Qhaem Hospital, Mashhad.
The patients, the surgeon, the outcome assessor, and the data analyzer would not be aware of the administered drugs.
Participants/Inclusion and exclusion criteria
The inclusion criteria include: 1.Patients suffering from skeletal class 3 deformity, requiring advancement of the maxilla with Lefort1 and setback of the mandible with BSSO (Bilateral Sagittal Split Osteotomy) technique. 2.Patients between 18 to 40 years old.3.Patients who are categorized in the 1st and 2nd group of the ASA classification.4.Patients who completed the informed consent. The Exclusion criteria include 1.Patients with a history of using analgesics or psychiatric medication during the previous month.2.Patients with a history of addiction or psychological problems 3.Patients with a history of drug allergy.4.Patients with a history of severe sinusitis.
Intervention groups
Intervention group: A single dose of 10 mg oral montelukast tablet ( made by Abidi pharmaceutical company under the brand name Airokast) will be dissolved in 20cc of apple juice and will be administered 1 hour before the surgery. Control group: Administration of 20cc of natural apple juice in which no drug or substance is dissolved as a placebo one hour before the surgery.
Main outcome variables
The amount of pain using the Visual analog scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150613022697N8
Registration date:2020-12-02, 1399/09/12
Registration timing:registered_while_recruiting
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Sahand Samiee rad
Name of organization / entity
mashhad dental school,oral and maxillofacial department
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 7289
Email address
samieerads@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-21, 1399/07/30
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of pre-operative administering of oral Montelukast on the pain amount following orthognathic surgery.
Public title
Evaluating the effect of Montelukast on pain following orthognathic surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients suffering from skeletal class 3 deformity, requiring advancement of the maxilla and set back of mandible using Lefort 1 and BSSO (Bilateral Sagittal Split Osteotomy ) technique respectively.
Patients between 18 to 40 years old.
Patients who are categorized in the 1st and 2nd group according to the ASA (American Society of Anesthesiology )
Patients who completed the informed consent.
Exclusion criteria:
Patients with a history of using analgesics or psychiatric medication during the previous month.
Patients with a history of addiction or psychological problems .
Patients with a history of drug allergy.
Patients with a history of severe sinusitis .
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Since the two groups are supposed to have the same sample size, the restricted randomization method and permuted block randomization will be used in this study.
Random block units will usually be used to balance the number of samples assigned to each of the groups studied.
The size of blocks will be selected randomly and there is an equal number of each group in each block.
Creating a random sequence will be performed by computer software " Random Allocation Software".
Random allocation concealment will be done using sequentially numbered, sealed, opaque envelopes by an independent person who does not know the study process.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the patient, surgeon, outcome assessor, and statistical analyzer will not be aware of the study groups. Regarding patients, blinding is so that patients will not know if they will receive a drug or a placebo. Regarding the assessor, the operator who delivers the pain questionnaires to the patient and completing the study checklist is not aware of the group assignment. The statistical analyzer will be blinded and all data will be provided in the form of coding to him. Furthermore, the anesthesiologist was aware of the drug types in order to prevent the peri- and postoperative complications.
Placebo
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 Science
Street address
Ghoreishi building, Daneshghah avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Approval date
2020-09-02, 1399/06/12
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1399.053
Health conditions studied
1
Description of health condition studied
Pain in Jaws
ICD-10 code
K10.9
ICD-10 code description
Disease of jaws, unspecified
Primary outcomes
1
Description
Amount of pain in the specified time period.
Timepoint
1 hour before the surgery and also 1 ,3 ,6 , 12 , 18 ,and 24 hours after the surgery.
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One dose of 10 mg oral montelukast tablet ( made by Abidi pharmaceutical company under the brand name Airokast) will be dissolved in 20cc of apple juice and will be administered to the patients 1 hour before the surgery.
Category
Rehabilitation
2
Description
Control group: Administration of 20cc of natural apple juice in which no drug or substance is dissolved as placebo one hour before the surgery.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and maxillofacial surgery department of Qaem hospital , Mashhad
Full name of responsible person
Sahand Samieerad
Street address
Mashhad Qaem hospital, Ahmadabad boulvard
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Fax
Email
samieerads@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Ghoreishi building, Daneshghah avenue.
City
Mashhad
Province
Razavi Khorasan
Postal code
91779448959
Phone
+98 51 3841 2081
Fax
+98 51 3841 2081
Email
TafaghodiM@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
Sahand Samieerad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sahand Samieerad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
samieerads@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirhooshang Ansari
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
oral and maxillofacial surgery department, Mashhad dental school, Vakil abad street.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3843 1448
Email
Hooshangansari1375@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
All collected data would be shared for all researchers after the participants were unidentified.
When the data will become available and for how long
The access to data will be started 6 months after publication
To whom data/document is available
The data would only be available for people working in academic institutions.
Under which criteria data/document could be used
It is allowed to use the data for meta-analysis and systematic reviews.
From where data/document is obtainable
The data can be obtained via email, from the corresponding researches (Dr Sahand samiee rad). E-mail: samieerads@mums.ac.ir
What processes are involved for a request to access data/document
The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission