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Comparison the Effectiveness of intravenous Ketamine and Precedex(dexmedetomidine) in the Relaxation of Pediatric Patients in Emergency Department

Protocol summary

Study aim
Comparison the Effectiveness of intravenous Ketamine and Precedex in the Relaxation of Pediatric Patients referred to Emergency Department
Design
Clinical trial of two groups with blind and randomized parallel form
Settings and conduct
This study was performed on children referred to emergency department of Imam Reza Hospital and Hasheminejad Hospital in Mashhad.In the group (A) 1.5-2 mg / kg, ketamine is injected intravenously once a day. In group (B), 2μg / kg Precedex drug will be injected within 10 minutes as the initial dose and then 2μg / kg Precedex will be injected intravenously as a second dose. Injections will be done by the investigator.Information about each patient, including age, sex, kind of drug that used for sedation, time duration to being sedate and recovery time using the Ramsy scale, will be recorded in the information form .The vital signs include BP, PR, RR, O2Sat, and the Ramsy scale of the patients will be measured at onset, 10 minutes after the injection, before the beginning of repair, and after the end of repairing the injury. patients and assessor will be blinded.
Participants/Inclusion and exclusion criteria
patients with the condition of needing a sedation to repair the injury and the age group of 2 to 12 years will be included in the study.Patients with unstable vital signs, patients with uncontrolled bleeding, deep tissue damage such as tendons and main vessels, respiratory infections, drug allergy , and patients with a history using of analgesic and sedative drugs are excluded from Study.
Intervention groups
n the group (A) 1.5-2 mg / kg, ketamine is injected intravenously once a day. In group (B), 2μg / kg Precedix drug will be injected within 10 minutes intravenously as the initial dose and then 2μg / kg Precedix will be injected intravenously.
Main outcome variables
time duration to being sedate and recovery time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161226031577N2
Registration date: 2018-07-09, 1397/04/18
Registration timing: registered_while_recruiting

Last update: 2018-07-09, 1397/04/18
Update count: 0
Registration date
2018-07-09, 1397/04/18
Registrant information
Name
behrang rezvani kakhki
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3761 4622
Email address
rezvanikb@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effectiveness of intravenous Ketamine and Precedex(dexmedetomidine) in the Relaxation of Pediatric Patients in Emergency Department
Public title
The effect of intravenous precedex on pediatric sedation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with the condition of needing a sedation to repair the injury Age group 2-12 years
Exclusion criteria:
Patients with unstable vital signs Patients with uncontrolled bleeding Deep tissues damage, such as the tendons and main vessels Patients with respiratory infections Drug susceptibility to drugs used Patients with a history of using analgesic and sedative drugs
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization Patients will be divided into two groups, A and B, by random number table. (The allocation of numbers to groups and directions is already determined,Put the pen on the table with blind eyes, Select the starting point)
Blinding (investigator's opinion)
Double blinded
Blinding description
The purpose of the study is explained to the patient's parents and their consent to participate in the study is taken.Assigning person and patient will not be informed of the assignment.The outcome evaluator will not be aware of how the medicine will be allocated to patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences ethical committee
Street address
Ghoreyshi Building, Daneshgah Strees, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9184938764
Approval date
2018-01-28, 1396/11/08
Ethics committee reference number
IR.MUMS.fm.REC.1396.534

Health conditions studied

1

Description of health condition studied
Patients requiring sedation to repair the injury of the hand
ICD-10 code
S61.41
ICD-10 code description
Laceration , hand

2

Description of health condition studied
Patients requiring sedation to repair the injury of the foot
ICD-10 code
S91.31
ICD-10 code description
Laceration, foot

Primary outcomes

1

Description
duration time to sedate and recovery time
Timepoint
At the initial time of entry, 10 minutes after the injection of the drug, before the repair is restored and after the injury is repaired
Method of measurement
Ramsy scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: percedex drug. Pridecox drug will be injected 2μg / kg intravenously as the initial dosea within 10 minutes and followed by 2μg / kg intravenously Precedix as the second dose.
Category
Treatment - Drugs

2

Description
Control group: Ketamin drug.1.5-2 mg / kg ketamine is injected intravenously once a day.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hasheminejad and Imam Reza hospitals
Full name of responsible person
Behrang rezvani Kakhki
Street address
Imam Reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
9184938764
Phone
+98 51 3804 9039
Email
rezvanikb@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Affair Of Mashhad University Of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mellat Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9184938764
Phone
+98 51 3800 2104
Email
Rezvanikb@mums.ac.ir
Grant name
Comparison the Effectiveness of intravenous Ketamine and Precedex(dexmedetomidine) in the Relaxation of Pediatric Patients in Emergency Department
Grant code / Reference number
10433
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Affair Of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Behrang Rezvani Kakhki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Hasheminezhad Hospital, Andishe Street, Tolab boulevard, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
12345
Phone
+98 51 3761 4622
Fax
+98 51 3852 5312
Email
Rezvanikb@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Behrang Rezvani Kakhki
Position
Assistant Professor of Emergency Medicine
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Hasheminezhad Hospital, Andishe Street, Tolab boulevard, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
12345
Phone
+98 51338049039
Fax
Email
rezvanikb@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Behrang Rezvani Kakhki
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Shahid Hasheminezhad Hospital, Andishe Street, Tolab boulevard, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
12345
Phone
+98 51 3761 4622
Fax
+98 51 3852 5312
Email
Rezvanikb@mums.ac.ir

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
there is no more information
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
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