The aim of current study is to evaluate the efficacy of tramadol added to ropivacaine compared to ropivacaine alone in caudal epidural block in children
Design
In this research, 46 children 3-10 years old undergoing lower abdomen surgeries with inclusion criteria and not having exclusion criteria will be included. Patients will be randomly allocated to ropivacaine alone or in combination with tramadol 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 combination with tramadol groups. The pain severity (using Modified Children’s Hospital of Eastern Ontario Pain Scale) after 1, 2 and 6 hours post surgery, type and dose of analgesics used and recovery time as well as possible side effects will be evaluated in each group. Patients' parents and the person evaluating the treatment outcome will be blinded to the allocated groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: American Society of Anesthesiologists class I and II, Surgery duration 30 minutes to 2 hours, No sensitivity to tramadol and ropivacaine. Exclusion criteria: Complicated surgeries (long or bleeding in need of transfusion), Parent do not consent for their child to participate
Intervention groups
After randomization, patients will receive ropivacaine 0.2% with proper dose per Kg alone or in combination with tramadol 2 mg /kg before extubation.
Main outcome variables
The main outcome variable will be pain severity using Modified Children’s Hospital of Eastern Ontario Pain Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190929044924N1
Registration date:2019-11-10, 1398/08/19
Registration timing:retrospective
Last update:2019-11-10, 1398/08/19
Update count:0
Registration date
2019-11-10, 1398/08/19
Registrant information
Name
Reza Farahmandrad
Name of organization / entity
Iran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8852 2083
Email address
farahmandrad.r@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacyof tramadol as an adjuvant to ropivacaine in pediatric caudal epidural block
Public title
Effect of tramadol as an adjuvant to ropivacaine in pediatric caudal epidural block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists (ASA) class I and II
Surgery duration 30 minutes to 2 hours
No sensitivity to tramadol and rupivacaine
Exclusion criteria:
Complicated surgeries (long or bleeding in need of transfusion)
Parent do not consent for their child 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 high way
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-10-23, 1397/08/01
Ethics committee reference number
IR.IUMS.FMD.REC.1398.107
Health conditions studied
1
Description of health condition studied
pain control
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain severity
Timepoint
One, 2 and 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: Patients in first group will receive ropivacaine 0.2% per body weight before extubation.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in second group will receive ropivacaine 0.2% per body weight with tramadol 2 mg/kg before extubation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul Akram Hospital
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
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
1449614535
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
Reza Farahmandrad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram Hospital, Niyayesh Ave., Satarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
farahmandrad.r@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Farahmand rad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram Hospital, Niyayesh Ave., Satarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
Farahmandrad.r@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Farahmandrad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram Hospital, Niyayesh Ave., Satarkhan
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
Farahmandrad.r@iums.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
We have not decided yet
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Undecided - It is not yet known if there will be a plan to make this available
When the data will become available and for how long
Undecided - It is not yet known if there will be a plan to make this available
To whom data/document is available
Undecided - It is not yet known if there will be a plan to make this available
Under which criteria data/document could be used
Undecided - It is not yet known if there will be a plan to make this available
From where data/document is obtainable
Undecided - It is not yet known if there will be a plan to make this available
What processes are involved for a request to access data/document
Undecided - It is not yet known if there will be a plan to make this available