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Comparison of pain relief effect of various doses of intravenous ketorolac at different times of mandibular fracture surgery

Protocol summary

Summary
In this clinical trial, 50 patients referred to Imam Reza Hospital with unilateral fracture of the mandible and indications for intra-oral Open Reduction treatment will be randomly selected and randomly divided into 5 groups. In this double-blind study, the surgeon and patients will be blinded to the study. Inclusion criteria: Patients with unilateral mandibular fracture Exclusion criteria: Duration of surgery more than 2 hours; Drug abuse by patients; History of systemic disease, History of drug allergy In Group A, immediately before induction of anesthesia a ketorolac 30 mg ampule, in Group B, immediately before induction of anesthesia a ketorolac 60 mg ampule, in Group C, immediately before the completion of surgery a ketorolac 30 mg ampule, in group D, immediately after the completion of surgery a ketorolac 60 mg ampule will be injected intravenously. It will not be injected for the Group E. After consciousness of the patient, intensity of pain(primary outcome variable) whit a numerical scale VAS at 0, 2, 4, 6, 12, 24 hours will be measured. Data from the study will be analyzed using appropriate statistical methods.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017031322951N4
Registration date: 2017-04-14, 1396/01/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-14, 1396/01/25
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
Tabriz University of Medical sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain relief effect of various doses of intravenous ketorolac at different times of mandibular fracture surgery
Public title
Comparison of pain relief effect of various doses of intravenous ketorolac at different times of mandibular fracture surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with unilateral mandibular fracture Exclusion criteria: Duration of surgery more than 2 hours; Drug abuse by patients; History of systemic disease, History of drug allergy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Postal code
Approval date
2016-08-29, 1395/06/08
Ethics committee reference number
IR.TBZMED.REC.1395.639

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified

Primary outcomes

1

Description
Pain Intensity
Timepoint
0, 2, 4, 6, 12,24 hours After surgery
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
In Group A(Intervention), immediately before induction of anesthesia a ketorolac 30 mg ampule will be injected intravenously
Category
Treatment - Drugs

2

Description
In Group B(Intervention), immediately before induction of anesthesia a ketorolac 60 mg ampule will be injected intravenously
Category
Treatment - Drugs

3

Description
In Group C(Intervention), immediately before the completion of surgery a ketorolac 30 mg ampule will be injected intravenously
Category
Treatment - Drugs

4

Description
In Group D(Intervention), immediately after the completion of surgery a ketorolac 60 mg ampule will be injected intravenously
Category
Treatment - Drugs

5

Description
In Group E(Control), Ketorolac ampule will not be injected
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Saeed Nezafati
Street address
Research deputy of Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sina Mirinejad
Position
Resident of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 9680
Fax
Email
milad.ghanizadeh@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sina Mirinejad
Position
Resident of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 9680
Fax
Email
milad.ghanizadeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Sina Mirinejad
Position
Resident of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 9680
Fax
Email
Milad.ghanizadeh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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