The Comparison of Bupivacaine, Bupivacaine-dexmedetomidine and Bupivacaine – fentanyl by caudal technique for postoperative analgesia in children 1-5 years old in pediatric hospital.
The aim of this study is to compare the effects of bupivacaine, bupivacaine-dexmedetomidine and bupivacaine-fentanyl with caudal technique for post operative analgesia. This double blinded clinical trial will be applied to 60 patients. Inclusion criteria: Children 1-5 years old, elective inguinal hernia operations. Exclusion criteria: cardiac-pulmonary congenital anomalies, history of drug allergy to the drugs used, contraindications to caudal block, cases with ASA class > I. The demographic and hemodynamic variables will be collected before and during and after anesthesia. induction and maintenance of anesthesia will be with sevoflurane in N2O and O2. before intubation of trachea atracurium 0.5 mg/kg will be applied. afterwards a caudal block will be done by an anesthesiologist. the first group will receive 1 ml/kg bupivacaine 0.25%, which will be prepared by adding equal volume of distilled water to 0.5% bupivacaine. the second group (bupivacaine-dexmedetomidine) will receive 1 ml/kg bupivacaine 0.25% with 2 µg/kg dexmedetomidine. The third group (bupivacaine-fentanyl) will receive 1 ml/kg bupivacaine 0.25% with 2 µg/kg fentanyl. intravenous fluid 6 ml/kg/hr during the operation and 4 ml/kg/hr after operation. Pain, sedation and motor block scores will be collected at 30 and 60 minutes of recovery and at 1, 2, 4, 6, 12 and 24 hours after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110318091N6
Registration date:2016-01-23, 1394/11/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-23, 1394/11/03
Registrant information
Name
Fekrat Fereydoon
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3334 4009
Email address
fereydoon.fekrat@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Bupivacaine, Bupivacaine-dexmedetomidine and Bupivacaine – fentanyl by caudal technique for postoperative analgesia in children 1-5 years old in pediatric hospital.
Public title
Comparing the effect of three local anesthesia drug regimes Bupivacaine, Bupivacaine-dexmedetomidine and Bupivacaine – fentanyl through an injection through the tail portion of the spinal column for providing postoperative analgesia in children one to five years old in a children's hospital.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children aged 1-5 years old; elective inguinal hernia operations. Exclusion criteria: cardiac-pulmonary congenital anomalies; history of drug allergy to the drugs used; contraindications to caudal block; cases with ASA class > I.
Age
From 1 year old to 5 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy for Research, and Medical Ethics Committee of Hormozgan University of Medical Sciences
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital,
City
Bandar Abbas
Postal code
7919915519
Approval date
2014-10-30, 1393/08/08
Ethics committee reference number
4-HEC-93-7-8
Health conditions studied
1
Description of health condition studied
Postoperative pain in children
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Pain
Timepoint
at time points of 30 and 60 minutes after operation in recovery room and at 1st, 2nd, 4th, 6th, 12th and 24th hours after operation in the surgery unit.
Method of measurement
Face Pain Scale Revise (FPS-R)
Secondary outcomes
1
Description
Heart rate
Timepoint
Every 10 minute after caudal block till and every 5 minute
10 minutes after caudal block till the start of operation and with 5 minute intervals till the end of operation
Method of measurement
Pulse oximeter device
3
Description
Arterial blood pressure
Timepoint
Every 10 minute after caudal block till and every 5 minute
Method of measurement
No ninvasive blood pressure monitoring device
4
Description
Sedation
Timepoint
At 30 and 60 minutes after operation in the recovery room and at the 1st, 2nd, 4th, 6th, 12th and 24th hours time points
Method of measurement
Michigan University Sedation Scale
Intervention groups
1
Description
First group (bupivacaine) which included 1 milliliter/kilogram from a solution of 0.25% buupivacaine which was prepared by adding distilled water to 0.5% bupivacaine with equal volumes.
Category
Prevention
2
Description
Second group (bupivacaine-dexmedetomidine) which included 1 milliliter/kilogram from a solution of 0.25% bupivacaine which was prepared by adding distilled water to 0.5% bupivacaine and 2 microgram/kilogram dexmedetomidine with equal volumes.
Category
Prevention
3
Description
Third group (bupivacaine-fentanyl) which included 1 milliliter/kilogram from a solution of 0.25% bupivacaine which was prepared by adding distilled water to 0.5% bupivacaine and 2 microgram/kilogram fentanyl with equal volumes.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Children Hospital
Full name of responsible person
Hashem Jarineshin
Street address
Goolshahr Shomali - Daroopakhsh Blvd.
City
Bandar Abbas
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Abdulazim Nejatizadeh
Street address
Joomhoori Islami Blv., Deputy of Research Center, Shahid Mohammadi Hospital
City
Bandar Abbas
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Assistant Professor of Anesthesiology and Intensive care, Fellowship of Cardiac Surgery Anesthesia
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.
City
Bandar Abbas
Postal code
7919915519
Phone
+98 76 3334 5009
Fax
+98 76 3334 5009
Email
hjarineshin@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Mohammadi Hospital
Full name of responsible person
Hashem Jarineshin
Position
Assistant Professor of Anesthesiology and Intensive care, Fellowship of Cardiac Surgery Anesthesia
Other areas of specialty/work
Street address
Shahid Mohammadi Hospital, Joomhoori Islami Blvd.
City
Bandar Abbas
Postal code
Phone
+98 76 3334 5009
Fax
Email
hjarineshin@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Fereydoon Fekrat
Position
Specialist in Anesthesiology and Intensive care
Other areas of specialty/work
Street address
Joomhoori Islami Blv., Shahid Mohammadi Hospital
City
Bandar Abbas
Postal code
7919915519
Phone
Fax
Email
fereydoonfekrat@yahoo.com
Web page address
http://anrc.resv.hums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)