Comparing the efficacy & safety of intravenous Oxycodon Vs intravenous Morphine used for post operative pain control, in patients undergoing laparathomy in Taleghani Hospital.
In this study our objective was comparing the efficacy & safety of intravenous Oxycodon Vs intravenous Morphine used for post operative pain control, in patients undergoing laparathomy in Taleghani Hospital. Inclusion Criteria were 25 to 75 years of age;signing testimonial;candidate for elective laparathomy
Exclusion Criteria were underling disease which can deviate the results;drug addiction;pregnancy;using enzyme inductors(Carbamazepine,Phenitoin);using enzyme inhibitors(fluxetine, Macrolids);hemodynamic unstablity after procedure;profuse bleeding during surgery. Patients candidate for elective laparatomy will receive two doses of Oxycodon or Morphine, first dose one hour before procedure is over, and the second dose, 12 hours after the end of procedure. Then the level of pain and prevalence of side effects will be compared between two groups (Oxycodon Vs Morphine) in first 24 hour after procedure
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081523620N1
Registration date:2015-10-10, 1394/07/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-10, 1394/07/18
Registrant information
Name
Mohammadreza Moshari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2595
Email address
rmoshari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy & safety of intravenous Oxycodon Vs intravenous Morphine used for post operative pain control, in patients undergoing laparathomy in Taleghani Hospital.
Public title
IV opioids effect in controlling post abdominal surgery pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria: 25 to 75 years of age;signing testimonial;candidate for elective laparathomy
Exclusion Criteria:underling disease which can deviate the results;drug addiction;pregnancy;using enzyme inductors(Carbamazepine,Phenitoin);using enzyme inhibitors(fluxetine, Macrolids);hemodynamic unstablity after procedure;profuse bleeding during surgery
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
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
Shahid Beheshti Medical University
Street address
VelenjakT,Tehran
City
Tehran
Postal code
Approval date
2015-07-26, 1394/05/04
Ethics committee reference number
IR.SBMU.RAM.REC.1394.93
Health conditions studied
1
Description of health condition studied
Apendicitis
ICD-10 code
K35.3
ICD-10 code description
Acute appendicitis with localized peritonitis
Primary outcomes
1
Description
Level of post operation pain
Timepoint
First 24 hour post operation period
Method of measurement
Vas Method
Secondary outcomes
empty
Intervention groups
1
Description
G1: 2mg Oxycodon in first 24 h post operaition period
G2: 2mg Morphine in first 24 h post operaition period
Category
Treatment - Drugs
2
Description
G2: 2mg Morphine in first 24 h post operaition period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Aytollah Taleghani Hospital
Full name of responsible person
Dr Reza Moshari
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farinaz Taheri Ms.
Street address
Taleghani Hospital, Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti Medical University
Full name of responsible person
Mohammadreza Moshari
Position
MD
Other areas of specialty/work
Street address
Taleghani Hospital, Velenjak,
City
Tehran
Postal code
Phone
+98 21 2243 2595
Fax
Email
rmoshari@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
Dr.Bahman Malek MD
Position
Assisstant Professor
Other areas of specialty/work
Street address
Taleghani Hospital,Velenjak
City
Tehran
Postal code
Phone
+98 21 2243 2595
Fax
Email
Bahman18871@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Moshari
Position
MD
Other areas of specialty/work
Street address
Taleghani Hospital, Velenjak
City
Tehran
Postal code
Phone
00
Fax
rmoshari@sbmu.ac.ir
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)