Comparison of Efficacy of Nebulized Ketamine with Intravenous Morphine in Patients with Multiple Trauma
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups used a random number table.
Settings and conduct
Obtaining written permission and randomization of patients using a table of random numbers; Age, sex, pain score, complications, need for additional doses of medication and type of injury in both groups at 0, 5, 10, 15, 30 and 60 minutes were recorded in a checklist and finally the data were entered into SPSS program.
Participants/Inclusion and exclusion criteria
Inclusion: Trauma patients with trauma pain with a pain score greater than 4/Age over 4 years/Age less than 65 years
Exclusion: Patients with level of consciousness 13/Housing consumption in the last 4 hours/History of seizures/Unsatisfied people to participating in the project/Psychedelics and drug addiction/Maxillofacial trauma in which the patient is unable to use a nebulizer mask/Systolic blood pressure less than 90 and more than 180/Respiratory rate less than 10/pulse rate Less than 60 and more than 140/Suspected of bleeding brain lesions or cerebral edema/Pregnancy/History of allergies to any of the drugs used in the study/Frequent nausea and vomiting/Brain Tumor/Glaucoma
Intervention groups
Intervention:1 mg/kg ketamine nebulizer with a maximum dose of 50 mg, which is brought to a volume of 3 cc with distilled water and poured into the nebulizer chamber, and connected with oxygen lit 5 min/min to 10 lit/min and cc 5 Slowly inject distilled water into a vein.
Control:Pour 3 cc of distilled water into the nebulizer and connect with 5 lit/min to 10 lit/min with oxygen and 0.1 mg/kg morphine with a maximum dose of 10 mg diluted with distilled water with a 5 cc syringe inject slowly into the peripheral vein.
Main outcome variables
Severity of pain measured by Visual Analogue Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200602047633N1
Registration date:2020-11-28, 1399/09/08
Registration timing:registered_while_recruiting
Last update:2020-11-28, 1399/09/08
Update count:0
Registration date
2020-11-28, 1399/09/08
Registrant information
Name
Zahra Rayat Roknabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3237 0718
Email address
zahra.rayat75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Efficacy of Nebulized Ketamine with Intravenous Morphine in Patients with Multiple Trauma
Public title
Comparison of Efficacy of Nebulized Ketamine with Intravenous Morphine in Patients with Multiple Trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Trauma patients with trauma pain with a pain score greater than 4
Age over 4 years
Age less than 65 years
Exclusion criteria:
Patients with level of consciousness 13
Housing consumption in the last 4 hours
History of seizures
Unsatisfied people to participating in the project
Psychedelics and drug addiction
Maxillofacial trauma in which the patient is unable to use a nebulizer mask
Systolic blood pressure less than 90 and more than 180
Respiratory rate less than 10
pulse rate Less than 60 and more than 140
Suspected of bleeding brain lesions or cerebral edema
Pregnancy
History of allergies to any of the drugs used in the study
Frequent nausea and vomiting
Brain Tumor
Glaucoma
Age
From 15 years old to 64 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table
Based on a random sequence of numbers from Random.org, a table will be prepared, with the first
Hundred consecutive numbers in Group A, the next Hundred consecutive numbers in Group B. These numbers will be assigned to each patient in order of referral.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drug is prepared and prescribed by the triage nurse based on which group the patient is in and none of the patients and the evaluating physician will know the type of prescription drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.023
Health conditions studied
1
Description of health condition studied
Patients with Multiple Trauma
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Response to treatment by reducing the pain intensity by two points (20 mm) in terms of visual analog scale (VAS).
Timepoint
Measurement of pain score at the beginning of the study (before the intervention) and 5, 10, 15, 30 and 60 minutes after the start of treatment
Method of measurement
visual analog scale (VAS)
Secondary outcomes
1
Description
Creating analgesia which patient's intensity pain goes below than 5.
Timepoint
Measurement of pain score at the beginning of the study (before the intervention) and 5, 10, 15, 30 and 60 minutes after the start of treatment
Method of measurement
visual analog scale (VAS)
2
Description
Determining the time to start treatment response in two groups
Timepoint
Measurement of pain score at the beginning of the study (before the intervention) and 5, 10, 15, 30 and 60 minutes after the start of treatment
Method of measurement
visual analog scale (VAS)
3
Description
Determining the frequency of patients who failed treatment in two groups
Timepoint
At the end of the study
Method of measurement
Calculate the number
4
Description
Determine the number of times the drug is prescribed
Timepoint
At the end of the study
Method of measurement
Calculate the number
Intervention groups
1
Description
Intervention group:1 mg / kg ketamine nebulizer with a maximum dose of 50 mg, which is brought to a volume of 3 cc with distilled water and poured into the nebulizer chamber, and connected with oxygen lit 5 min / min to 10 lit / min and cc 5 Slowly inject distilled water into a vein.
Category
Treatment - Drugs
2
Description
Control group:Pour 3 cc of distilled water into the nebulizer and connect with 5 liters / min to 10 lit / min with oxygen and 0.1 mg / kg morphine with a maximum dose of 10 mg diluted with distilled water with a 5 cc syringe We inject the face slowly into the peripheral vein.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Soheila Azimi
Street address
Shahid Ghandi Blvd, Ebne Sina Blvd
City
Yazd
Province
Yazd
Postal code
8916886938
Phone
+98 35 3822 4000
Email
Sadoughi_Hospital@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Shahid Rahnemoun Hospital
Full name of responsible person
Dr. Soheila Azimi
Street address
Farrokhi St., Emergency Alley
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3626 0001
Email
Rahnemoonhospital@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Yazd, Bahonar Square, the central building of Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Zahra Rayat Roknabadi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Emergency Medicine
Street address
8965113337, House of Mohammad Rayat, Roknabad, Meybod, Yazd
City
Yazd
Province
Yazd
Postal code
8965113337
Phone
+98 35 3237 0718
Fax
Email
zahra.rayat75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Soheila Azimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
بلوار ابن سینا
City
Yazd
Province
Yazd
Postal code
8913893111
Phone
+98 35 3828 2682
Fax
Email
soheila.azimi1987@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zahra Rayat Roknabadi
Position
Medical Student
Latest degree
A Level or less
Other areas of specialty/work
Emergency Medicine
Street address
8965113337, House of Mohammad Rayat, Roknabad, Meybod, Yazd
City
Yazd
Province
Yazd
Postal code
8965113337
Phone
+98 35 3237 0718
Fax
Email
zahra.rayat75@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