The aim of this study is to compare the effects of intravenous and intranasal ketorolac in patients undergoing mandibular fracture surgery.
Design
Clinical trial with a sample size of 54 patients in two parallel groups, without blindness
Settings and conduct
This study will perform among patients referred to Emam Reza Hospital in Tabriz with unilateral mandibular fracture. After surgery, patients are randomly divided into two groups. In the first group, 30 ml intravenous ketorolac ampule will be injected every 8 hours. In the second group, the 15% intranasal ketorolac spray will be used every 6 hours. Then, the severity of pain in patients will be recorded and compared 2, 4, 6, 8, 12, 24, 36 and 48 hours after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with unilateral fracture of mandible in body and angle region, that have not been fracture for more than 3 months.
Exclusion criteria: Addicted patients
Intervention groups
In the first group, patients undergoing mandibular fracture surgery, receive analgesic ampoule's of ketorolac. In the second group, patients receive ketorolac intra nasal spray.
Main outcome variables
Severity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150628022951N8
Registration date:2018-09-14, 1397/06/23
Registration timing:prospective
Last update:2018-09-14, 1397/06/23
Update count:0
Registration date
2018-09-14, 1397/06/23
Registrant information
Name
milad Ghanizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
milad.ghanizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Analgesic Efficacy of intravenous and intranasal ketorolac in patients undergoing mandibular fracture surgery
Public title
Effect of ketorolac Spray on Reducing Pain in Patients with mandible Fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral fracture of mandible in body and angle region, Which has not been fractured for more than 3 months
Exclusion criteria:
Addicted patients
Age
From 20 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used. Each person will be assigned a code, and according to the random number table, each person will be placed in a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-03-02, 1396/12/11
Ethics committee reference number
IR.TBZMED.REC.1396.1270
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
Pain Intensity
Timepoint
2, 4, 6, 8, 12, 24, 36 and 48 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous injection of 30 mg ketorolac ampoule every 8 hours
Category
Treatment - Drugs
2
Description
Intervention group: Intranasal 15% ketorolac spray every 6 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Farhad Nojan
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615739
Phone
+98 41 3335 9680
Fax
Email
milad.ghanizadeh@gmail.com
Web page address
https://www.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolgasem Joyban
Street address
Research deputy of Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
researchteam.tbzmed@gmail.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
Javad Yazdani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
Ja_yazdani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farhad Nojan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
milad.ghanizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farhad Nojan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
milad.ghanizadeh@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
Demographic information of patients and data related to the outcomes of the study (pain intensity) will be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Sharing data for meta-analysis
From where data/document is obtainable
Please contact Dr. Farhad Nojan by e-mail: researchteam.tbz@gmail.com
What processes are involved for a request to access data/document
After ensuring that your claim is true, these data will be sent to you.