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A clinical trial to compare the effectiveness of opioid with opioid-ketamine on pain relief in traumatic patients

Protocol summary

Study aim
A clinical trial to compare the effectiveness of opioid with opioid-ketamine on pain relief in traumatic patients
Design
In clinical trial with a control group and double-blind, eighty traumatic patients were chosen allocated using table of random numbers, community-based and pragmatic as parallel groups.
Settings and conduct
Traumatic patients who referred to the emergency department of Besat Hospital, Tehran are chosen as the participants of the study. In this double-blind study, the participants and all of responsible for data collection are unaware of the patient's groups and the type of drug
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged between 15 and 40 years; having a natural intelligence; no speech problem; according to the diagnosis patients with trauma require the analgesic. Exclusion criteria: Allergy to the drugs studied; having underlying disorder of respiratory, cardiac, neurological; addicted; active psychosis; poisoning clinical.
Intervention groups
The control group is receiving 20 mg opioid with distilled water. The intervention group is receiving 10 mg opioid with 0.1 mg/kg ketamine.
Main outcome variables
Evaluation and comparison of opioid with opioid-ketamine of pain relief based on the visual analog scale, and side-effects of medications (nausea and vomiting, dizziness, dry mouth, euphoria, skin rash in the area of injection, nystagmus, tinnitus, etc) based on questionnaire before, 15 and 30 minutes after intervention between the control and intervention groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181021041399N1
Registration date: 2018-11-07, 1397/08/16
Registration timing: prospective

Last update: 2018-11-07, 1397/08/16
Update count: 0
Registration date
2018-11-07, 1397/08/16
Registrant information
Name
Mehdi Arzani Sams Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3321 6512
Email address
ziahejri@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of opioid with opioid-ketamine on pain relief in traumatic patients
Public title
The effective of opioid-ketamine on pain relief in traumatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 15 and 40 years Having a natural intelligence No speech problem according to the diagnosis patients with trauma require the analgesic
Exclusion criteria:
Allergy to the drugs studied Having underlying disorder of respiratory, cardiac, neurological Addicted Active psychosis Poisoning clinical
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Eighty traumatic patients who are referred to the emergency department of Besat Hospital, were chosen allocated using table of random numbers. To this end, a code is allocated to each of the participants to be assigned into one of the two groups of intervention or control
Blinding (investigator's opinion)
Double blinded
Blinding description
Traumatic patients who referred to the emergency department of Besat Hospital, are chosen as the participants of the study. In this double-blind study, the participants and all of responsible for data collection are unaware of the patients groups and the type of drug.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Republic of Iran Army University of Medical Sciences
Street address
Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.AJAUMS.REC.1397.011

Health conditions studied

1

Description of health condition studied
Traumatic arthropathy
ICD-10 code
M12.5
ICD-10 code description
Traumatic arthropathy

2

Description of health condition studied
injuries of head
ICD-10 code
S09
ICD-10 code description
Other and unspecified injuries of head

3

Description of health condition studied
Injury of abdominal
ICD-10 code
S35.0
ICD-10 code description
Injury of abdominal aorta

4

Description of health condition studied
Injury of hand region
ICD-10 code
S68.3
ICD-10 code description
Combined traumatic amputation of (part of) finger(s) with other parts of wrist and hand

5

Description of health condition studied
Injury of hand leg
ICD-10 code
T05.4
ICD-10 code description
Traumatic amputation of one foot and other leg [any level, except foot]

Primary outcomes

1

Description
pain relief
Timepoint
before, 15 and 30 minutes
Method of measurement
visual analog scale

Secondary outcomes

1

Description
side-effects of medications (nausea and vomiting, dizziness, dry mouth, euphoria, skin rash in the area of injection, nystagmus, tinnitus, etc)
Timepoint
before, 15 and 30 minutes after intervention
Method of measurement
Designed questionnaire

Intervention groups

1

Description
Control group: who is receiving 20 mg opioid with distilled water
Category
Treatment - Drugs

2

Description
Intervention group: who is receiving 10 mg opioid with 0.1 mg/kg ketamine.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Nahaja Hospital
Full name of responsible person
Mehdi Arzani Shams Abadi
Street address
Besat Nahaja Hospital, Basij Highway
City
Tehran
Province
Tehran
Postal code
1735838544
Phone
+98 21 3321 6512
Email
info@website.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohammad Solemani
Street address
Vice Chancellor for Research, Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 3321 6512
Email
info@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Mehdi Arzani Shams Abadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 3321 6512
Email
me_arzani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mehdi Arzani Shams Abadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 3321 6512
Fax
Email
me_arzani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mehdi Arzani Shams Abadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Islamic Republic of Iran Army University of Medical Sciences, Etemadzadeh Street, Fatemi Street
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 3321 6512
Email
me_arzani@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results.
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Mehdi Arzani Shams Abadi provides the analysis code to the applicants via email: me_arzani@yahoo.com
What processes are involved for a request to access data/document
Data collection was done for 10 months, data were collected one month, statistical analysis of one month, information dissemination as a article six months.
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