Protocol summary
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Study aim
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Comparison of intranasal administration with intravenous injection of dexmedetomidine in postoperative pain control of mandibular fractures
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Pain intensity
General information
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Reason for update
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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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Acronym
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IRCT registration information
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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
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Registration date
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2023-12-19, 1402/09/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-01-19, 1402/10/29
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Expected recruitment end date
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2024-03-18, 1402/12/28
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of intranasal administration with intravenous injection of dexmedetomidine in postoperative pain control of mandibular fractures
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Public title
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Comparison of intranasal administration with intravenous injection of dexmedetomidine in postoperative pain control of mandibular fractures
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-08-05, 1402/05/14
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Ethics committee reference number
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IR.TBZMED.REC.1402.341
Health conditions studied
1
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Description of health condition studied
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Pain intensity
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ICD-10 code
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G89.11
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ICD-10 code description
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Acute pain due to trauma
Primary outcomes
1
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Description
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Pain intensity
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Timepoint
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Every two hours for 24 hours after surgery
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available