The aim of this study was the comparison of the analgesic effect of morphine and paracetamol in the patients undergoing Cholecystectomy , using IV-PCA method
Seventy patients who had undergone Cholecystectomy were studied using double blind randomized clinical trial (35 patients in both groups) in the Shahid Rajaee Center and Velayat Hospital.Inclusion criteria include: ASA 1 and 2 patients 15 to 65 years who were undergoing Cholecystectomy Operation takes less than 2.5 hours.Exclusion criteria include: People using opioids, painkillers and sedatives regularly and in large doses and patients with a history of lung or liver problems. The parameters of the severity of pain and nausea (VAS), hemodynamic changes (BP , HR), pruritus, o2 saturation and patient satisfaction (VAS) of both groups were measured by a trained colleague.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012712298N1
Registration date:2013-05-19, 1392/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-19, 1392/02/29
Registrant information
Name
Reza Pourfallah
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3272 0831
Email address
rpoorfallah@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2010-08-01, 1389/05/10
Expected recruitment end date
2011-08-01, 1390/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Paracetamol and Morphine with IV-PCA in control of postop pain in Cholecystectomy
Public title
Effect of Paracetamol on Postop Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :patients with ASA 1 and 2 ; 15 to 65 years ; who were undergoing Cholecystectomy Operation ; takes less than2.5 hours.Exclusion criteria : People using opioids, painkillers and sedatives regularly and in large doses ; patients with a history of lung problems ;patients with a history of liver problems
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar bolivar, Qazvin
City
Qazvin
Postal code
34185-745
Approval date
2012-06-25, 1391/04/05
Ethics committee reference number
28-20-6031
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
Z90.4
ICD-10 code description
Acquired absence of other parts of digestive tract
Primary outcomes
1
Description
Post Operative Pain
Timepoint
2, 4, 6 and 8 Hours after Intervention
Method of measurement
VAS
Secondary outcomes
1
Description
Nausea
Timepoint
2, 4, 6 And 8 Hours After Intervention
Method of measurement
VAS
2
Description
Satisfaction
Timepoint
2, 4, 6 and 8 Hours after Intervention
Method of measurement
VAS
3
Description
Pruritus
Timepoint
2, 4, 6 and 8 Hours after Intervention
Method of measurement
Yes or no
4
Description
Arterial Oxygen Desaturation
Timepoint
2, 4, 6 and 8 Hours after Intervention
Method of measurement
Yes or no
5
Description
Changes in Blood Pressure
Timepoint
2, 4, 6 and 8 Hours after Intervention
Method of measurement
Into three groups: Low, Medium and High
6
Description
Changes in Heart rate
Timepoint
2, 4, 6 and 8 Hours after Intervention
Method of measurement
Into three groups: low, medium and high
Intervention groups
1
Description
Paracetamol. Controlling pain after laparotomy surgery (Cholecystectomy). with maximum dose 125 mg per hour with intravenous PCA. Lasting 8 hours after surgery
Category
Treatment - Drugs
2
Description
Morphine. Controlling pain after laparotomy surgery (cholecystectomy). with maximum dose 20.0 mg per kg in hour with intravenous PCA. Lasting 8 hours after surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaii Hospital
Full name of responsible person
Reza Pourfallah
Street address
No 88, khalag Ave, shahid fahmideh Sq
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University Of Medical Scienses
Full name of responsible person
Reza Pourfallah
Street address
No88, khalaj Ave, shahid fahmide Sq
City
Karaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University Of Medical Scienses
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
Qazvin University of Medical Sciences
Full name of responsible person
Reza Pourfallah
Position
Resident of anestesiology
Other areas of specialty/work
Street address
No88, khalaj Ave, shahid fahmide Sq
City
Karaj
Postal code
Phone
+98 26 3272 0831
Fax
Email
rpoorfallah@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Siamak Yaqubi
Position
Intensivist
Other areas of specialty/work
Street address
Shahid Rajaii Hospital
City
Qazvin
Postal code
Phone
+98 26 3272 0831
Fax
Email
siamak yaqubi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reza Oourfallah
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
No88, khalaj Ave, shahid fahmide Sq
City
Karaj
Postal code
Phone
+98 26 3272 0831
Fax
Email
rpoorfallah@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)