The Goal of this study is the evaluation of pethidine and midazolam versus propofol and fentanyl on pain control during extracorporeal shock wave lithotripsy. This single blind clinical trial will be done on75 patients with renal stones who are candidates for extracorporeal shock wave lithotripsy in Imam Ali Hospital. Patients should be alert and have class1 and class2 America Society of Anesthesiologists scale (ASA) and no history of chronic use of analgesics or narcotics. Patients will be randomly allocated into two groups (using Random numbers table). First group will receive Intravenous Pethidine and midazolam (20 to 40 milligram pethidine and 1 to 2 milligram midazolam) and another group will receive Intravenous propofol and fentanyl (1.5 mg/ kg propofol and 1 Microgram / kg fentanyl) before beginning extracorporeal shock wave lithotripsy. The extracorporeal shock wave lithotripsy will be done according to standard methods in both groups. The level of pain experienced by patients will be evaluated at 15, 30, 45 and 60 minutes after finishing the procedure with visual analogue scale (VAS)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051427893N1
Registration date:2016-11-24, 1395/09/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-24, 1395/09/04
Registrant information
Name
Ramin Haghighi
Name of organization / entity
North Khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3272 4475
Email address
haghighi.ramin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Esfarayen University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of pethidine and midazolam versus propofol and fentanyl on pain control during extracorporeal shock wave lithotripsy
Public title
The effects of drugs on the pain after Lithotripsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write.
Having consciousness in extent proper communication.
No history of chronic use of narcotics and analgesics.
No history of mental disorders.
Age of 15-80 years old.
Exclusion criteria:
If the patient does not consent to be excluded.
If deeper anesthesia and using other drugs is necessary.
Having allergy to propofol, pethidine, midazolam or fentanyl.
Age
From 15 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random numbers table was used for the randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfarayen University of Medical Sciences
Street address
Medical Sciences Esfarayen, Taleghani Avenue, Esfarayen, North Korasan, Iran
City
Esfarayen
Postal code
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.ESFARAYENUMS.REC
Health conditions studied
1
Description of health condition studied
Kidney Stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Severity of pain
Timepoint
In the times of 15, 30, 45 and 60 minutes after Intervention
Method of measurement
Visual Pain Scale (VAS)
Secondary outcomes
1
Description
Satisfaction
Timepoint
After a full consciousness of the patient
Method of measurement
Using the checklist and self-report scale
Intervention groups
1
Description
First group will receive Intravenous Pethidine and midazolam (20 to 40 milligram pethidine and 1 to 2 milligram midazolam) before beginning extracorporeal shock wave lithotripsy.
Category
Treatment - Drugs
2
Description
another group will receive Intravenous propofol and fentanyl (1.5 mg/ kg propofol and 1 Microgram / kg fentanyl) before beginning extracorporeal shock wave lithotripsy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Haghighi Ramin Fellowship in Endourology and Urolaparoscopy
Street address
Imam Ali Hospital, Shahriar Ave, Bojnourd, Iran
City
Bojnourd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Esfarayen University of Medical Sciences
Full name of responsible person
Shoja Mohsen
Street address
Medical Sciences Esfarayen, Taleghani Avenue, Esfarayen, North Korasan, Iran
City
Esfarayen
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Esfarayen 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
North Khorasan University of Medical Sciences
Full name of responsible person
Ahmad Kameli
Position
Instructor
Other areas of specialty/work
Street address
School of Nursing, Shahriar Ave, Bojnourd, Iran
City
Bojnourd
Postal code
Phone
+98 58 3229 6909
Fax
Email
ahmad_kamely@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Ahmad Kameli
Position
Instructor
Other areas of specialty/work
Street address
School of Nursing, Shahriar Ave, Bojnourd, Iran
City
Bojnourd
Postal code
Phone
+98 58 3229 6909
Fax
Email
ahmad_kamely@uahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Ahmad Kameli
Position
Instructor
Other areas of specialty/work
Street address
School of Nursing, Shahriar Ave, Bojnourd, Iran
City
Bojnourd
Postal code
Phone
+98 58 3229 6909
Fax
Email
ahmad_kamely@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)