The aim of this study was to compare the effects of analgesia and intravenous and intravenous ketamine in patients with nasal fracture.
Design
In this study, patients with diagnosed nasal fractures will be included in the study. Patients will be divided into 2 groups described. Randomization has not been followed. The sample size for each group would be 32 in total, 64. The study will be conducted in Phase 3. Blood pressure is measured before the injection of the medication. During pain reduction, patients' pain levels will be measured based on the VAS score.
Settings and conduct
The study will be performed at Fatemi Hospital in a randomized, non-blinded, case-control study.
Participants/Inclusion and exclusion criteria
In this study, patients diagnosed with nasal fracture who were admitted for nasal closure in Ardabil Fatemi hospital, after obtaining consent to enter the study and recording their demographic characteristics, will be included in the relevant questionnaires.
Intervention groups
The first group of patients receiving subcutaneous ketamine (0.5 mg / kg) in the anterior forearm 10 minutes before reduction, 7 minutes after midazolam (0.03 mg / kg) and fentanyl (1.5μg / kg). The second group received intravenous ketamine (0.3 mg / kg), followed by midazolam (0.03 mg / kg) and fentanyl (1.5 µg / kg) for 3 minutes.
Main outcome variables
The main variable of the study is the pain scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191011045060N1
Registration date:2020-01-26, 1398/11/06
Registration timing:registered_while_recruiting
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
Shaghayegh Delshad Namin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 0739
Email address
sh.delshad@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of analgesia and complications of subcutaneous and intravenous ketamine in closed reduction of nasal fracture
Public title
Comparison of the effects of analgesia and complications of subcutaneous and intravenous ketamine in closed reduction of nasal fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 5 to 60 years
Patients with nasal fractures
Exclusion criteria:
Drug sensitivity or anesthesia
Pregnancy
History of seizures
History of hypertension
comoncold
History of brain trauma
Age
From 5 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
N/A
Randomization description
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 Ardabil University of Medical Sciences
Street address
No. 1, Daneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
5613843793
Approval date
2019-08-25, 1398/06/03
Ethics committee reference number
IR.ARUMS.REC.1398.276
Health conditions studied
1
Description of health condition studied
Nasal fracture
ICD-10 code
S02.2XXA
ICD-10 code description
Fracture of nasal bones, initial encounter for closed fracture
Primary outcomes
1
Description
Pain scale
Timepoint
When you enter the recovery ward, then 15 and 30 minutes later
Method of measurement
The pain will be measured on a VAS scale. In this model, pain scores of 0 and the most pain a patient can imagine are recorded with a score of 10.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intervention group 1:. The first group of patients receiving subcutaneous ketamine (0.5 mg / kg) who will be injected into the anterior forearm.
Category
Treatment - Drugs
2
Description
Intervention group: The second group will receive intravenous ketamine (0.3 mg / kg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi hospital
Full name of responsible person
Shagayegh Ddelshad
Street address
No. 1, Mollem Ave
City
Aedabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
sh.delshad@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvane Naftchi
Street address
No. 1, Mmoallem Ave
City
Ardabil
Province
Ardabil
Postal code
5613843587
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Vadood norouzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Emam Khomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Vadood Norouzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Emam Khomeyni Ave
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Vadood Norouzi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 1, Emam Khomeyni Ave.
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@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
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The questionnaires will be made available anonymously and with a file number.
When the data will become available and for how long
After completing the study
To whom data/document is available
University professors
Under which criteria data/document could be used
In order to find out how to work in SPSS file, anonymous questionnaires will only be available with file number.
From where data/document is obtainable
Contact Dr. Shaghayegh Delshad E-mail (sh.delshad@arums.ac.ir)
What processes are involved for a request to access data/document
Information is available after contacting Dr. Shaghayegh Delshad and University approval