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General information
80
70
8070
empty
This study was designed and conducted with 70 patients. Recruiting 80 patients would be time-consuming; therefore, if possible, please record the number of 70 patients in the system.
This study was designed and conducted with 70 patients. Recruiting 80 patients would be time-consuming; therefore, if possible, please record the number of 70 patients in the system.
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این مطالعه با تعداد 70 بیمار باید انجام شودو انجام شد؛ دسترسی به تعداد 80 بیمار زمان بر خواهد بود؛ لذا در صورت امکان تعداد 70 بیمار در این سامانه ذکر شود.
این مطالعه با تعداد 70 بیمار باید انجام شودو انجام شد؛ دسترسی به تعداد 80 بیمار زمان بر خواهد بود؛ لذا در صورت امکان تعداد 70 بیمار در این سامانه ذکر شود.
Protocol summary
Study aim
Comparison of intranasal administration with intravenous injection of dexmedetomidine in postoperative pain control of mandibular fractures
Design
In this double-blind clinical trial study (participants and results analyzer), patients will undergo surgery after random allocation in the two mentioned groups. For one group, dexmedetomidine drug will be injected intranasally and for the other group, this drug will be injected intravenously, the intensity of pain after surgery will be compared between the two groups.
Settings and conduct
In this double-blind clinical trial study (participants and results analyzer), patients will undergo surgery after random allocation in the two mentioned groups. For one group, dexmedetomidine drug will be injected intranasally and for the other group, this drug will be injected intravenously, the intensity of pain after surgery will be compared between the two groups.
Participants/Inclusion and exclusion criteria
The most important criteria for entering the study include: patients with ASA class I, II, candidates for mandibular fracture surgery and consent to participate in the present research project, and the most important exclusion criteria include: patients with a history of high blood pressure, patients taking medications Lowering blood pressure will be patients using beta blockers and patients with a history of heart diseases.
Intervention groups
In this study, patients who will refer to the operating room due to lower jaw fractures will undergo intervention. Patients will be randomly divided into two groups. For one group, dexmedetomidine drug will be injected intranasally and for the other group, this drug will be injected intravenously, the intensity of pain after surgery will be compared between the two groups.
Main outcome variables
Pain intensity
General information
Reason for update
This study was designed and conducted with 70 patients. Recruiting 80 patients would be time-consuming; therefore, if possible, please record the number of 70 patients in the system.
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N40
Registration date:2023-12-19, 1402/09/28
Registration timing:prospective
Last update:2024-08-20, 1403/05/30
Update count:1
Registration date
2023-12-19, 1402/09/28
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-19, 1402/10/29
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intranasal administration with intravenous injection of dexmedetomidine in postoperative pain control of mandibular fractures
Public title
Comparison of intranasal administration with intravenous injection of dexmedetomidine in postoperative pain control of mandibular fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA class I, II
candidate for mandibular fracture surgery
Consent to participate in this research project
Exclusion criteria:
Patients with a history of high blood pressure
Patients taking antihypertensive drugs
Patients taking beta blockers
Patients with a history of heart disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, with a sample size of 80, we use the patients using the block permutation randomization method, which is used in this method to balance the number of allocated samples, and with 4 people in each block. We assemble the possible blocks as follows. block 1: BBAA, block 2: AABB, block 3: ABAB, block 4: BABA, block 5: ABBA, and block 6: BAAB, we need 20 blocks for 80 people. It is random in the block method. We choose numbers from one to six. For example, if number 6 is chosen as the first block and number 2 as the second block, the people who enter the study will be given BAABAABB in order from left to right. and finally they were divided into two intervention groups (group A) and control group (group B).
Blinding (investigator's opinion)
Double blinded
Blinding description
The thesis results analyst who will analyze the expected result and also the participants will be unaware of the type of procedure performed and will be blind during the study; Therefore, this study will be conducted in a double-blind manner. Since the participants will be unaware of the type of drug used, in this study they will not know what type of drug will be used in other patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2023-08-05, 1402/05/14
Ethics committee reference number
IR.TBZMED.REC.1402.341
Health conditions studied
1
Description of health condition studied
Pain intensity
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Pain intensity
Timepoint
Every two hours for 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the patients of this group (intranasal administration), this drug will be administered at the rate of 0.2 mcg/kg half an hour before the start of anesthesia (in the form of drops). Then the pain intensity will be checked every two hours in the first 24 hours after the surgery with the help of the pain intensity tool.
Category
Treatment - Drugs
2
Description
Control group: For the patients of this group (intravenous injection), this drug will be administered at the rate of 0.5 micrograms/kg of the drug as a bolus within ten minutes and half an hour before anesthesia. Then the pain intensity will be checked every two hours in the first 24 hours after the surgery with the help of the pain intensity tool.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mehdi Khanbabayi Gol
Street address
Azadi Ave, Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@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
Undecided - It is not yet known if there will be a plan to make this available
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