The aim of current study is to evaluate the efficacy of dexmedetomidine in adjunct to ropivacaine compared to ropivacaine alone before extubation in pediatric caudal epidural block.
Design
In this research, 46 patients undergoing lower abdomen surgeries with inclusion criteria and not having exclusion criteria r will be included. Patients will be randomly allocated to ropivacaine alone or in adjunct to dexmedetomidine groups and each patient will be given a specific code.
Settings and conduct
After patients selection, they will be randomly allocated to ropivacaine alone or in adjunct to dexmedetomidine groups. Pain severity (using Modified Children’s Hospital of Eastern Ontario Pain Scale) after 1, 2 and till 6 hours post surgery, the amount and type of analgesics used, recovery duration and possible side effects will be evaluated in both groups. Patients' parents and the person evaluating the treatment outcome will be unaware of the allocated groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 3-10 years, ASA class I or II, Lower abdomen and below epigastric surgeries including hernia and UDT, surgery period 30 minutes to 2 hours, no sensitivity to ropivacaine and dexmedetomidine. Exclusion criteria: complicated surgeries (long or bleeding in need of transfusion), Parents do not agree for children to participate.
Intervention groups
After randomization, before extubation one group will receive ropivacaine 0.2% 1.5 mg/kg alone and other group will receive ropivacaine 0.2% 1.5 mg/kg with dexmedetomidine 1 microgram per kg.
Main outcome variables
The main outcome of the study is pain severity using Modified Children’s Hospital of Eastern Ontario Pain Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111102007984N30
Registration date:2019-10-05, 1398/07/13
Registration timing:registered_while_recruiting
Last update:2019-10-05, 1398/07/13
Update count:0
Registration date
2019-10-05, 1398/07/13
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
farnadimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of dexmedetomidine as an adjuvanct to ropivacaine in pediatric caudal epidural block
Public title
Efficacy of dexmedetomidine as an adjuvanct to ropivacaine in pediatric caudal epidural block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA class I or II
Lower abdomen and epigastric surgeries like hernia and UDT
Surgery time between 30 minutes and 2 hours
No sensitivity to dexmedetomidine and ropivacaine
Exclusion criteria:
Complicated surgeries (long or bleeding in need of transfusion)
Parents do not give consent for their children to participate
Age
From 3 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
By using the randomize number table, the patients were divided into two equal groups (n=23).
Blinding (investigator's opinion)
Double blinded
Blinding description
Both drugs are injectable and the injection site of both drugs in the patients' body is in the same area. Therefore, patients' parents are not aware of the type of drug. Also, the outcome evaluator is unaware of the random allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Expressway corner
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-12-09, 1397/09/18
Ethics committee reference number
IR.IUMS.FMD.REC.1398.077
Health conditions studied
1
Description of health condition studied
Postoperative pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Postoperative pain
Timepoint
One, two and till 6 hours after surgery
Method of measurement
Using Modified Children’s Hospital of Eastern Ontario Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First group will receive ropivacaine 0.2%, 1.5 mg/kg (maximum 25 mg) before extubation.
Category
Treatment - Drugs
2
Description
Intervention group: The second group will receive ropivacaine 0.2%, 1.5 mg/kg (maximum 25 mg) in adjunct to dexmedetomedine 1 microgram per kg before extubation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat- Rasul Akram Medical Coplex
Full name of responsible person
Farnad Imani
Street address
Anesthesiology and pain department of Hazrat-Rasoul Medical Complex, Niayesh street, Sattar-Khan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 6651 5758
Fax
Email
farnadimani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakoti
Street address
Iran University of Medical Sciences, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Interventional pain fellowship, professor of anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Email
farnadimani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Interventional pain fellowship, professor of anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Email
farnadimani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Interventional pain fellowship, professor of anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pain Research Center, Department of Anesthesiology and Pain Medicine, Rasool Akram Medical Center, Niayesh St. Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Email
farnadimani@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
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
Title and more details about the data/document
Some part of the clinical information of the patients will be shared
When the data will become available and for how long
6 months after the end of the project
To whom data/document is available
Faculty Members of Medical Sciences Universities
Under which criteria data/document could be used
For further studies
From where data/document is obtainable
Deputy of Research & Technology Pain Research Center, Iran University of Medical Sciences
What processes are involved for a request to access data/document
First, at the request of the university, she/he will be informed at the request of the university's deputy of the research department, and then she/he will be referred to the research center during the administrative process and the data will be received by the committee of the research center of the center with a commitment and acceptance.