Protocol summary

Summary
An external organ crusher noninvasive method to break stones using the administrative apparatus Shock waves are acoustic waves, but these effects cause temporary pain and discomfort in the deep waves of entry is visceral. Housing that require administration over the action necessary to make this study on 159 patients to the hospital for surgery ESWL Ayatollah Kashani was referred 53 patients to three-person groups were assigned randomly: the first group, intravenous pethidine mg 25 alone, the second group, intravenous pethidine mg 25 plus topical piroxicam gel, and the third group mg 25 gel lidocaine with intravenous pethidine Flank position in the area for half an hour before surgery patients were used. During the operation each patient had unbearable pain again mg 25 pethidine was injected intravenously. Postoperative Pain Questionnaire based MC Gill was measured. Results showed that all three groups with different age and sex were not significant and significant difference in pain scores in three groups of patients there was a (P< 0.01) measure of average pain in the first group (pethidine) 6.2 ± 6.9 and the second group (pethidine piroxicam gel) 2.7 ± 2.3 and the third group (pethidine lidocaine gel) 3.1 ± 3.9 was. Mean difference in pain pethidine group and the other groups was significant. (P< 0.05) Average amount of drug use in the first group pethidine (pethidine alone) 24 ± 16 mg, the second group (pethidine+ piroxicam gel) 5 ± 9 mg and the third group (pethidine +lidocaine gel) 10 ± 13 mg. Average differences in drug taking pethidine with two other groups had significant differences (P< 0.05) .This study showed that piroxicam gel or lidocaine reduces pain in patients after ESWL, and the need for drug consumption reduces.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811043156N1
Registration date: 2010-12-29, 1389/10/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-12-29, 1389/10/08
Registrant information
Name
Mohammad Moazeni Bistgani
Name of organization / entity
Shahrekord University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 4445
Email address
drmoazeni@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
shahrekord university of medical sceinces
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2009-09-23, 1388/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Effect of intravenous injection of pethidine plus piroxicam or lidocaine gel topical in reducing pain during the ESWL and comparison with intravenous injection of pethidine alone
Public title
Study of Effect of topical piroxicam or lidocaine in reducing pain during the ESWL and compared with intravenous injection of pethidine alone
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion : want to participate in the plan- absence severe hydronephrosis Exclusion: Presence severe hydronephrosis
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 159
Randomization (investigator's opinion)
N/A
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
shahrekord university of medical sciences
Street address
aiatollah kashahni street
City
shahrekord
Postal code
Approval date
2009-02-21, 1387/12/03
Ethics committee reference number
9-12-87

Health conditions studied

1

Description of health condition studied
Pain during ESWL
ICD-10 code
N 20.0
ICD-10 code description
Calculus of kidney

Primary outcomes

1

Description
pain
Timepoint
immediatly after ESWL
Method of measurement
McGill Questionnaire during ESWL procedure

Secondary outcomes

empty

Intervention groups

1

Description
petidin (IV) 25 mg + lidokaein gel
Category
Other

2

Description
petidin (IV)25 mg + piroxicam gel
Category
Other

3

Description
petidin (IV) 25 mg
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
aiatollah kashani educational therapy center
Full name of responsible person
aiatollah kashani educational therapy center
Street address
City
shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
shahrekord university of medical sciences
Full name of responsible person
dr. mobasheri mahmood
Street address
research assistant
City
shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
shahrekord 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
shahrekord university of medical sceinces
Full name of responsible person
dr.moazeni bistgani mohammad
Position
thoracic surgeon
Other areas of specialty/work
Street address
aiatollah kashani educational therapy center
City
shahrekord
Postal code
Phone
+98 38 1222 4445
Fax
Email
drmoazeni@skums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
shahrekord university of medical sciences
Full name of responsible person
dr. moazeni bistgani mohammad
Position
thoracic surgeon
Other areas of specialty/work
Street address
aiatollah kashani educational therapy center
City
shahrekord
Postal code
Phone
+98 38 1222 4445
Fax
Email
drmoazeni@skums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
dr. moazeni bistgani mohammad
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
drmoazeni@skums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...