In this clinical trial, we compare local anesthetic and analgesic effects tramadol and lidocaine for circumcision. 60 boys, candidate for circumcision procedure with full healthy condition, age between 0-5 years, without any external genital congenital abnormality and without any sensitivity to study drugs included to trial.
At group 1, surgeon will inject lidocaine 4 mg/kg, with 25 gauge needle by infiltration at base of penis and at group 2, surgeon will inject tramadol 2 mg/kg, with 25 gauge needle by infiltration at base of penis. We measured patients for pain assessment at the time of intervention, five, ten and twenty minutes after the intervention and the results were presented.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106183468N7
Registration date:2011-09-22, 1390/06/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Mohammad Reza Hajiesmaeili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00983516227747-00983517232422
Email address
hajiesmaeili@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Pain Research Center, Shahid Sadoughi University of Medical Science and Health Services
Expected recruitment start date
2011-08-22, 1390/05/31
Expected recruitment end date
2011-10-22, 1390/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of local anesthetic effects of tramadol with lidocaine for circumcision procedure.
Public title
Comparison of tramadol with lidocaine for circumcision procedure.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: full physical health; age 0-5 years
Exclusion criteria: anatomical malformation; sensitivity to study drug
Age
To 5 years old
Gender
Male
Phase
N/A
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
Shahid Sadoughi University of Medical Science and Health Services
Street address
Shahid Bahonar Squire, Yazd, Iran
City
Yazd
Postal code
8919895746
Approval date
2011-08-03, 1390/05/12
Ethics committee reference number
پ/17/1/57201
Health conditions studied
1
Description of health condition studied
circumcision
ICD-10 code
Z41.2
ICD-10 code description
Routine and ritual circumcision
Primary outcomes
1
Description
pain
Timepoint
at intervention-1-5-10-20 minute after intervention
Method of measurement
CHIOPS (Children's Hospital of Eastern Ontario Pain Scale)
2
Description
total analgesic consumption
Timepoint
24 after intervention
Method of measurement
mg/kg consumped ibuprofen
3
Description
time to first analgesic request
Timepoint
time between intervention and first analgesic administratin
Method of measurement
minutes
Secondary outcomes
1
Description
side effects
Timepoint
24 hours after intervention
Method of measurement
observation
Intervention groups
1
Description
at group 1, surgeon will inject lidocain4 mg/kg, with 25 gague needle by infiltration at base of penis.
Category
Other
2
Description
at group 2, surgeon will inject tramadol 2 mg/kg, with 25 gague needle by infiltration at base of penis.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afshar Hospital
Full name of responsible person
Dr Mohammad Hossein Mirshamsi
Street address
Afshar Hospital, Jomhoori Bol, Yazd, Iran
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pain Research Center
Full name of responsible person
Dr Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pain Research Center
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
Shahid Sadoughi University of Medical Sciences and health services, Yazd, Iran
Full name of responsible person
Dr Mohammad Hossein Mirshamsi
Position
Assistant Professor of Surgery
Other areas of specialty/work
Street address
Afshar Hospital, Yazd, Iran
City
Yazd
Postal code
Phone
+98 983518224001
Fax
Email
drmirshamsi@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Science and Health Services
Full name of responsible person
Dr Mohammad Reza Hajiesmaeili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Rahnemoon Hospital
City
Yazd
Postal code
Phone
+98 35 1626 8111
Fax
+98 35 1622 7747
Email
hajiesmaeili@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and health services, Yazd, Iran
Full name of responsible person
Dr Mohammad Reza Hajiesmaeili
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shahid Rahnemoon Hospital
City
YAZD
Postal code
Phone
+98 35 1622 7747
Fax
+98 35 1622 7747
Email
hajiesmaeili@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)