Extracorporeal shock wave lithotripsy is a non invasive procedure allows urinary stones to be broken.The shock wave because pain and discomfort in entry site and deep viscera. A cooperative patient is essential in maintaining stone targeting for optimal fragmentation during extra corporeal shock wave lithotripsy (ESWL). Therefore, it is important to choose an appropriate analgesic, sedation with minimal adverse effects intravenous acetaminophen is a non opioid analgesic and primary act on central nervous system by way of cyclooxygenase inhibition. All the healthy patient who candidate only for ESWL can come to study. The exclusion criteria are contraindication to use opioids; severe chronic respiratory disease and severe obesity.There are no need to use placebo because study is not blind. In this study patients are divided in three groups. Group A receive only sufentanyl and propofol. Group B receive sufentanyl and propofol plus paraacetamol. Group C receive sufentany and propofol plus music playing. Pain evaluation is by numerical pain scale every five minute during ESWL. The primary end point of this study is to compare effect of intravenous acetaminophen with music playing on pain perception in ESWL. The secondary end point is s occurrence of respiratory depression in PACU
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301151936N10
Registration date:2013-01-27, 1391/11/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-01-27, 1391/11/08
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2013-01-29, 1391/11/10
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative effect of paracetamol vs music playing on pain in extra corporeal shock wave lithothrepsy
Public title
The comparative effect of paracetamol vs music playing on pain in extra corporeal shock wave lithothrepsy
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria are: the patients who candidate only for ESWL and American Society of Anesthesiologist( ASA )score I or II.
The exclusion criteria are contraindication to use opioids; severe chronic respiratory disease and severe obesity.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences Ethics Committee
Street address
Bushehr -Bushehr University of Medical Sciences
City
Bushehr
Postal code
Approval date
2012-11-21, 1391/09/01
Ethics committee reference number
B-91-14-3
Health conditions studied
1
Description of health condition studied
Pain durinng ESWL
ICD-10 code
N99.9
ICD-10 code description
Postprocedural disorder of genitourinary system, unspecified
Primary outcomes
1
Description
Pain during ESWL
Timepoint
45 minutes
Method of measurement
Numerical analogous pain scale
Secondary outcomes
1
Description
Occurence of respiratory depression
Timepoint
60 minutes
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Patient divided to 3 equals groups. Group A(n=45) (control group) receive 30 micrograms per kilogeram per minute propofol plus10 sufentanli. Pain assessed every 5 minute by numerical pain score(0= no pain,10=severe pain) and in situation that it will be over 3 a rescue doses of sufentanil(2.5 micrograms ) will be injected.
Category
Prevention
2
Description
Patient divided to 3 equals groups. Group B(n=45) (intervention group) receive 30 micrograms per kilogeram per minute propofol plus 10 micrograms sufentanil and 15 micrograms of paraacetamol per minute. Pain assessed every 5 minute by numerical pain score(0= no pain,10=severe pain) and in situation that it will be over 3 a rescue doses of sufentanil(2.5 micrograms ) will be injected
Category
Prevention
3
Description
Patient divided to 3 equals groups. Group C(n=45) intervention group)receive 30 micrograms per kilogram per minute propofol plus 10 micrograms of sufentanil and music playing during ESWL. Pain assessed every 5 minute by numerical pain score(0= no pain,10=severe pain) and in situation that it will be over 3 a rescue doses of sufentanil(2.5 micrograms ) will be injected
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
BENTOLHODA HOSPITAL
Full name of responsible person
Dr.najafianaraki
Street address
bushehr-fatemezahra hospital
City
bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr majid asadi
Street address
Bushehr university of medical science
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Najafi Anaraki
Position
Assistant Professor
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 1252 6801
Fax
Email
dr.najafianaraki@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Najafi Anaraki
Position
Assistant Professor
Other areas of specialty/work
Street address
Bushehr university of medical science
City
Bushehr
Postal code
Phone
+98 77 1252 6801
Fax
Email
dr.najafianaraki@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Assistant Professor
Other areas of specialty/work
Street address
Bushehr-Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)