Protocol summary

Summary
Aim: assessment of the effect of the addition of dexmedetomidine to low dose bupivacaine on the duration of anesthesia in the caudal block after lower abdominal surgeries. Target population: one to 6-year-oldchildren who were class ASA 1 and candidates for lower abdominal surgeries and have been referred to the children hospital of TUMS. Inclusion criteria: class ASA 1 children who were between 1 and 6 years old and were candidates for lower abdominal surgeries and caudal block. Exclusion criteria: developmental delay hx; hemostasis disorders; antiplatelet medication use; sensitivity to the used drugs in the study; local infection in the caudal block site or congenital anomalies; pre-operational need for analgesics. Interventions: two-hundred children were randomly divided into two groups. For all patients, 33 mg/kg bolus infusion of methyl prednisolone was administered in 15 min. For control group, the caudal block was done using 1 mg/kg of bupivacaine+ normal saline (1 cc/kg volume), and in the study group this procedure was performed using 1 mg/kg of bupivacaine + 1 micro/kg of dexmedetomidine (1 cc/kg volume) The pain scale after surgery, the first time that the patients need analgesics and their dose in the first 24 hours, the total amount of analgesics used in 24 hours and the time of voluntary leg movements and urination were assessed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080513947N8
Registration date: 2017-08-15, 1396/05/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-15, 1396/05/24
Registrant information
Name
Atta Mahdkhah
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1332 6196
Email address
mshimia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the addition of dexmedetomidine to low dose bupivacaine on the duration of anaesthesia in the caudal block after lower abdominal surgeries
Public title
The effect of the addition of dexmedetomidine to low dose bupivacaine on the duration of anaesthesia in the caudal block after lower abdominal surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: class ASA 1 children who were between 1 and 6 years old and were candidates for lower abdominal surgeries and caudal block. Exclusion criteria: developmental delay hx; hemostasis disorders; antiplatelet medication use; sensitivity to the used drugs in the study; local infection in the caudal block site or congenital anomalies; pre-operational need for analgesics.
Age
From 1 year old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee and Research,Tabriz University of Medical Sciences
Street address
Iran, Tabriz, Golgasht Street, Ethics Committee and Research,Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2017-05-08, 1396/02/18
Ethics committee reference number
IR.TBZMED. REC.1396.118

Health conditions studied

1

Description of health condition studied
Local anaesthetics
ICD-10 code
Y48.3
ICD-10 code description
Anaesthetics and therapeutic gases

Primary outcomes

1

Description
The pain scale after surgery
Timepoint
4, 8, 12, 24 h after of operation
Method of measurement
Evaluation of the pain scale after surgery with FLACC behavioral tool for children under 3 years old and Baker-Wong FACES rating scale for children older that 3 years

Secondary outcomes

1

Description
The time of voluntary leg movements and urination were assessed.
Timepoint
After operation
Method of measurement
by expert nurse

2

Description
The first time that the patients need analgesics and their dose in the first 24 hours, the total amount of analgesics used in 24 hours
Timepoint
24h
Method of measurement
after admission in ward and by expert nurse

Intervention groups

1

Description
For all patients, 33 mg/kg bolus infusion of methyl prednisolone was administered in 15 min. For control group, the caudal block was done using 1 mg/kg of bupivacaine+ normal saline (1 cc/kg volume)
Category
Treatment - Drugs

2

Description
For all patients, 33 mg/kg bolus infusion of methyl prednisolone was administered in 15 min. In the study group this procedure was performed using 1 mg/kg of bupivacaine + 1micro/kg of dexmedetomidine (1 cc/kg volume)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences, Children hospital
Full name of responsible person
Dariush Sheikhzadeh
Street address
Tabriz, Sheshkalan street, Children hospital
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dariush Sheikhzadeh
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dariush Sheikhadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1332 6196
Fax
Email
dr.d.sheik@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dariush Sheikhzadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3337 6953
Fax
Email
dr.arsalan2010@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dariush Sheikhzadeh
Position
Assistatnt prof.
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1332 6196
Fax
Email
dr.d.sheik@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...