Comparison of analgesic effects of morphine with the standard dose of 0.1mg / kg and morphine at a dose of 0.05mg / kg with ketamine at a dose of 0.3mg / kg in patients with multiple trauma
Reduction of Morphine use in Patients with Multiple Trauma
Design
Clinical trial, prospective, double-blind, randomized with computer software with a sample size of 70 patients
Settings and conduct
Multiple trauma patients eligible for the study who referred to the emergency department of Al-Zahra and Kashani hospitals in Isfahan were included in the study.And then divided into two groups: 35 patients in the morphine group (0.1 mg / kg, morphine IV is administered for pain control) and 35 patients in the combined group ( 0.1 mg / kg morphine and mg /kg0.3 Ketamine IV).Meanwhile, morphine was diluted in the first group to achieve an equal volume of the second group.Before injection, the pain level is asked according to the VAS score (numerical scale 10-0), and after injection, 10, 20 and 30 minutes later, the pain level is asked and, If at these times the pain of the patient according to the VAS score was still above 3, 3mg of additional morphine was injected in both groups, as well as possible side effects were recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:: Multiple trauma patients aged 16-50 years who are alert and have stable vital signs.
Exclusion criteria: psychosis, history of cardiovascular disease, penetrating eye trauma, and pulse rate less than 60 beat per minute
Intervention groups
In order to relieve pain in the intervention group, low dose ketamine and low dose morphine are prescribed.The usual dose of morphine and the placebo is administered in the control group .
Main outcome variables
Severity of pain before and after injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038549N3
Registration date:2018-03-05, 1396/12/14
Registration timing:registered_while_recruiting
Last update:2018-03-05, 1396/12/14
Update count:0
Registration date
2018-03-05, 1396/12/14
Registrant information
Name
Farhad Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8804
Email address
drfarhadheydari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-04-19, 1397/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effects of morphine with the standard dose of 0.1mg / kg and morphine at a dose of 0.05mg / kg with ketamine at a dose of 0.3mg / kg in patients with multiple trauma
Public title
Reduced Morphine Consumption Using Low Dose Ketamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple trauma patients
Alert
Stable vital signs
Exclusion criteria:
Psychosis
cardiovascular disease
open globe injuries
severe head trauma
RR<60/min
Age
From 16 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
Both groups were given morphine and then, for blindness in the control group, in addition to the morphine, 5 cc of normal saline is prescribed instead of ketamine.Meanwhile, morphine was diluted in the control group to achieve an equal volume of intervention.Syringes are pre-prepared in binary form and used in each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Alzahra hospital,Sofe Ave., Shahid Keshvari Blvd.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Approval date
2016-07-22, 1395/05/01
Ethics committee reference number
IR.MUI.REC.1395.3.824
Health conditions studied
1
Description of health condition studied
Pain in Multiple Trauma Patients
ICD-10 code
T07
ICD-10 code description
Unspecified multiple injuries
Primary outcomes
1
Description
Pain score
Timepoint
The times are zero (moment of injection) and 10, 20 and 30 minutes
Method of measurement
Visual Analogue Scale(0-10)
2
Description
Side effects
Timepoint
10, 20 and 30 minutes after injection
Method of measurement
Count the number of items registered in the checklist
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before injection, 10, 20 and 30 minutes later
Method of measurement
Manometer( pressure gauge)
2
Description
Heart rate
Timepoint
Before injection, 10, 20 and 30 minutes later
Method of measurement
Count
3
Description
Respiratory rate
Timepoint
Before injection, 10, 20 and 30 minutes later
Method of measurement
Count
4
Description
Oxygen saturation level
Timepoint
Before injection, 10, 20 and 30 minutes later
Method of measurement
Pulse oximetry
5
Description
Patient Satisfaction
Timepoint
30 minutes after injection
Method of measurement
4-level Likert table
Intervention groups
1
Description
Intervention group:morphine 0.05mg / kg and ketamine IV 0.3 mg / kg
Category
Treatment - Drugs
2
Description
Control group: Morphine 0.1 mg / kg and placebo 5 cc IV
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra and Kashani hospital
Full name of responsible person
Farhad Heydari
Street address
Alzahra Hospital,Sofeh Ave.,Shahid Keshvari Blvd
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3620 2020
Email
drfarhadheydari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Street address
Alzahra Hospital,Sofeh Ave.,Shahid Keshvari Blvd.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3620 2020
Email
drfarhadheydari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No 7, Aria Building, Sohrevardi Ave.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No 7, Aria Building, Sohrevardi Ave.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No7, Aria Building, Sohrevardi Ave.
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD