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Investigating the Analgesia and Sedation Effects of Ketamine Infusion and Intravenous Morphine in Reducing the Pain of Short and Long Bone Fractures of Upper or Lower Extremities

Protocol summary

Study aim
A Comparative Study on the Effects of Ketamine and Morphine Antinociception in Bone Fractures
Design
Clinical trial based on traumatic patients referred to Imam and Golestan Hospital, Ahwaz, Iran, randomized
Settings and conduct
Imam Khomeini Hospital and Golestan Hospital Ahvaz
Participants/Inclusion and exclusion criteria
The criteria for entering the study are all patients with aged 65-18 years old trauma who go directly to the emergency department. In this study, all people with any history of ketamine, morphine, evidence of abnormal brain such as hydrocephalus, microcephaly, lumps, evidence of increased intracranial pressure, seizure, apnea history, respiratory problems, airway problems, heart problems And vascular, history of severe brain trauma, no premeditated sedimentation and the need for a higher dose of the drug, and also if the patient is dissatisfied with the research.
Intervention groups
Investigating the effect of ketamine and morphine in the fracture of the bone
Main outcome variables
Analgesia, sedation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170716035105N3
Registration date: 2018-04-09, 1397/01/20
Registration timing: retrospective

Last update: 2018-04-09, 1397/01/20
Update count: 0
Registration date
2018-04-09, 1397/01/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 1064
Email address
khalighi.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2017-07-11, 1396/04/20
Trial completion date
empty
Scientific title
Investigating the Analgesia and Sedation Effects of Ketamine Infusion and Intravenous Morphine in Reducing the Pain of Short and Long Bone Fractures of Upper or Lower Extremities
Public title
The effect of analgesia and sedation of ketamine and morphine in bone fractures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The criteria for entering the study are all patients with aged 65-18 years old trauma who go directly to the emergency department.
Exclusion criteria:
In this study, all people with any history of ketamine, morphine hypersensitivity, evidence of abnormal brain such as hydrocephalus, microcephaly, lumps, evidence of increased intracranial pressure, seizure, apnea history, respiratory problems, airway problems, heart problems And vascular, history of severe brain trauma, no premeditated sedimentation and the need for a higher dose of the drug, and also if the patient is dissatisfied with the research.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 120
Actual sample size reached: 166
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients at a later stage, history, examination, and consent to withdraw from the project at any stage of the research will enter the project. In this study, the drugs are individually and in the same format, along with the way of prescribing the drug in similar boxes and placed in a secret box tank Possible side effects of medications have been made so that in case of any complications, the observer will be able to quickly take the patient out of the research and treat it. During the registration process all signs and symptoms will be made by the practitioner. After the completion of the process, the procedure will be announced to the organizer for review.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Khuzestan.Hawaz, Golestan Highway, Jundishapur University of Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
64519
Approval date
2016-02-07, 1394/11/18
Ethics committee reference number
ir.ajums.rec.1396.248

Health conditions studied

1

Description of health condition studied
Investigating the fracture of long bones
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
38/5000People with long bone fracture
Timepoint
Scoring the pain intensity at 0, 5, 15, 30, 60
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital, Ahvaz Golestan Hospital
Full name of responsible person
Meysam Moezi
Street address
Imam Khomeini Hospital, Ahvaz Golestan Hospital, Golestan Ave., 24th Street, Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
64519
Phone
+98 61 3374 1064
Email
meisam.moezzi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
meisam.moezzi
Street address
Imam Khomeini Hospital, Ahvaz Golestan Hospital, Golestan Ave., 24th Street, Ahwaz
City
ahvaz
Province
Khouzestan
Postal code
64519
Phone
+98 61 3374 1064
Email
meisam.moezzi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
meisam mozzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
64519
Phone
+98 61 3374 1064
Email
meisam.moezzi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
meisam moezzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
64519
Phone
+98 633741064
Email
Meisam.moezzi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
meisam moezzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Golestan Hospital
City
Ahvaz
Province
Khouzestan
Postal code
64519
Phone
+98 61 3374 1064
Email
meisam.moezzi@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
publish article
When the data will become available and for how long
2018
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
test k
From where data/document is obtainable
mehri.zahra08@gmail.com
What processes are involved for a request to access data/document
Notify by email or phone
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