The aim of this study was to compare the efficacy and complications of Fentanyl and combination of Midazolam and Pethedine for pain control in ESWL. One hundred Patients, older than 18 years old with renal or upper ureteral stones with size between 6-25 millimeter who were candidate for extracorporeal shockwave lithotripsy (ESWL), were randomly allocated into one of two study groups to receive 50 milligrams of Pethedine as well as 1 milligram of Midazolam or only 50 micrograms of Fentanyl. The medications were injected intravenously 5 minutes before ESWL. In both groups, procedures were done in supine position under fluoroscopic guidance by standard technique until intolerance of patients or giving maximum shock of 4000. During the procedure, oxygen saturation was checked by pulse oximetery. Blood pressure and severity of pain through visual analogue scale were checked every 20 minutes until two hours. After ESWL, the patients were followed up for two hours and the patients’ satisfaction was checked by seven point verbal scale. Two weeks later, sonography was done to see if ESWL had worked and also if any adverse effect had happened during that time.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711051323N2
Registration date:2010-05-29, 1389/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor Yasuj University of Medical Sciences
Expected recruitment start date
2008-08-20, 1387/05/30
Expected recruitment end date
2010-04-29, 1389/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and complications of Fentanyl and combination of Midazolam and Pethedine for pain control in ESWL
Public title
Comparison of efficacy and complications of Fentanyl and combination of Midazolam and Pethedine for pain control in ESWL
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 18 years, renal or upper ureteral stone, stone size between 6-25 mm
Exclusion criteria: Presence of Coagulopathy, presence of neuropathy, stone size more than 25mm in kidney and more than 15mm in ureter, presence of active infection, presence of azotemia, uncontrolled hypertension, hypersensitivity to narcotic drugs, pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee Yasuj University of Medical Sciences
Street address
Yasuj university of Medical Sciences, Motahari street, Yasuj, Iran
City
Yasuj
Postal code
7591741417
Approval date
empty
Ethics committee reference number
2620/5/23/پ
Health conditions studied
1
Description of health condition studied
Calculus of kidney and ureter
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
pain
Timepoint
Before procedure and every 20 minutes during operation and one hour later
Method of measurement
Visual analoge scale
Secondary outcomes
1
Description
clerance of kidney or ureter from the stone
Timepoint
2 weeks later
Method of measurement
ultrasonography and KUB
2
Description
Pulmunary or cardiovascular complications
Timepoint
Before procedure and every 20 minutes during the operation and one hour later
Method of measurement
Checking blood pressure every 20 minutes and Pulseoximetey during the procedure
Intervention groups
1
Description
intravenous injection of 50 mligrams Pethedin and 1 miligram Midazolam, 5 minutes before ESWL
Category
Treatment - Drugs
2
Description
intravenous injection of 50 microgram of Fentanyl 5 minutes before ESWL
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Behehti Hospital
Full name of responsible person
Dr Sadrollah Mehrabi
Street address
Shaheed Behesti Hospital Shaheed Montazeri Street
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research manager of Yasuj University of Medical Sciences
Full name of responsible person
Dr Mehdi Akbartabar
Street address
Emam Sajad Hospial, Research Vice chancelor of Yasuj University of Medical Sciences
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research manager of Yasuj 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
Urology Department, Yasuj University of Medical Sciences
Full name of responsible person
Dr Sadrollah Mehrabi
Position
Associate profesoor, Felloship of endourology and urolaparoscopy
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street, Yasuj
City
Yasuj
Postal code
7591741417
Phone
+98 74 1222 6517
Fax
+98 74 1222 6517
Email
mehrabi390@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Department, Yasuj University of Medical Sciences
Full name of responsible person
Dr Sadrollah Mehrabi
Position
Associate profesoor, Felloship of endourology and urolaparoscopy
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street, Yasuj
City
Yasuj
Postal code
7591741417
Phone
+98 74 1222 6517
Fax
+98 74 1222 6517
Email
mehrabi390@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Department, Yasuj University of Medical Sciences
Full name of responsible person
Dr Sadrollah Mehrabi
Position
Associate profesoor,Felloship of endourology and urolaparoscopy
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Motahari street, Yasuj
City
Yasuj
Postal code
7591741417
Phone
+98 74 1222 6517
Fax
+98 74 1222 6517
Email
mehrabi390@yahoo.com and dr mehrabiyums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)