Management of post operative pain in the children who have undergone hypospadiasis repair accounts for optimized surgery outcomes and improved patients’ satisfaction. Thus, various studies have widely investigated the best approaches for this pain management.
In this double-blind, randomized clinical trial, 42 patients undergoing surgical treatment of hypospadias were divided into a case (n=23) and a control (n=19) group to receive either IV dexamethasone 0.5 mg/kg or placebo (normal saline) during the operation. Penile block was also performed in both groups using Bupivacaine 0.5% (1mg/kg) at the end of the procedure. FLACC pain scoring system was used for evaluation of post opperative pain. Patients aged between 1- 6 years old who had distal hypospadiasis. Patients with other types of hypospadiasis or those with other associated congenital anomalies were excluded from study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030416840N1
Registration date:2014-06-08, 1393/03/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-08, 1393/03/18
Registrant information
Name
Behnam Nasihatkon
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 1006
Email address
nasihatb@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2013-03-01, 1391/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of dexamethasone on postoperative analgesia in the children undergoing hypospadias repair
Public title
Efficacy of dexamethasone on postoperative analgesia in the children undergoing hypospadias repair
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients aged between 1- 6 years old who had distal hypospadiasis. Exclusion criteria: patients with other types of hypospadiasis or those with other associated congenital anomalies
Age
From 1 year old to 6 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Shiraz University of Medical Sciences(Vice-Chancellor for research)
Street address
Shiraz university of Medical Sciences- Zand Blvd. ,Shiraz, Iran
City
Shiraz
Postal code
Approval date
2014-05-10, 1393/02/20
Ethics committee reference number
2014-201
Health conditions studied
1
Description of health condition studied
Distal hypospadias
ICD-10 code
Q54.0
ICD-10 code description
Hypospadias, balanic
Primary outcomes
1
Description
Post-operative pain
Timepoint
in the recovery room and after 2, 6, 12, and 24 hours
Method of measurement
FLACC pain scoring system
Secondary outcomes
empty
Intervention groups
1
Description
The patients of the intervention group received 0.5 mg/kg dexamethasone during operation.
Category
Treatment - Drugs
2
Description
The patients in control group got the same volume of normal saline during operation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Mehdi Shirazi M.D.
Street address
Namazi sq. , Zand blvd , Shiraz, Iran
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Mehdi Shirazi M.D.
Street address
Beside school of medicine, Zand blvd, Shiraz, Iran
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences, Vice-Chancellery of Research and Technology
Full name of responsible person
Dabaghmanesh MH M.D.
Street address
Shiraz University of Medical Sciences, Zand blvd. , Shiraz , Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences, Vice-Chancellery of Research and Technology
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
Shiraz University of Medical Sciences
Full name of responsible person
Behnam Nasihatkon
Position
Resident of Urology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 1628 6587
Fax
Email
nasihatb@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
histomorphometry and stereology research center, shiraz university of medical sciences
Full name of responsible person
Mehdi Shirazi
Position
Associate professor
Other areas of specialty/work
Street address
shiraz university of medical sciences, shiraz, Iran
City
Shiraz
Postal code
Phone
+98 917 711 1354
Fax
Email
shirazim@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Behnam Nasihatkon
Position
Resident of Urology
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand blvd, Shiraz, Iran
City
Shiraz
Postal code
1433671348
Phone
+98 71 1230 5410
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)