The aim of this study was the comparison of the analgesic effect of Morphine and Paracetamol and Ketorolac with IV_PCA in 330 patients undergoing open cholecystectomy , were studied using double blind randomized clinical trial ( 110 patients in each groups ) in the Shahid Rajaee Centre and Velayat Hospital.inclusion criteria include :ASA 1and 2 patients 20 _50 years who were undergoing open cholecystectomy operation takes less than 2.5 hours.Exclusion criteria include: People using opioids, painkillers and sedatives regularely and in large doses and patients with ahistory 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) were measured by a trained colleague.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031717048N1
Registration date:2014-09-17, 1393/06/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-17, 1393/06/26
Registrant information
Name
Monadi Hamidfar
Name of organization / entity
Qazvin University medical sience
Country
Iran (Islamic Republic of)
Phone
+98 33 35800
Email address
mhamidfar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Science
Expected recruitment start date
2013-09-14, 1392/06/23
Expected recruitment end date
2014-08-14, 1393/05/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Paracetamol and Morphine and Ketorolac with IV_PCA in control of post operative pain in open cholecystectomy
Public title
Comparison the effect of Morphine ,Paracetamol and Ketorolac with Patient Control Analgesia in post operative pain in open cholecystectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Patient with ASA 1 and 2 ; 20 _50 years ; who werwe undergoing open cholecystectomy operation ; takes less than 2.5 hours .
Exclusiom criteria : People using opioids , painkillers and sedatives regularely and in large doses.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
330
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
shahid Bahonar bolivar , Qazvin
City
Qazvin
Postal code
Approval date
2013-09-04, 1392/06/13
Ethics committee reference number
7783/20/28
Health conditions studied
1
Description of health condition studied
Pain control
ICD-10 code
R10.1
ICD-10 code description
Pain localized to upper abdomen
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
In to three groups: Low, medium and high
6
Description
changes in heart rate
Timepoint
2, 4, 6 and 8 hours after intervention
Method of measurement
in to three groups : low , medium and high
Intervention groups
1
Description
Morphine, controlling pain after laparatomy surgery (cholecystectomy). with maximum dose 0.02 mg per kg in hour with intravenous PCA. lasting 8 hour after surgery.
Category
Treatment - Drugs
2
Description
Paracetamol. controlling painafter laparotomy surgery (cholecystectomy). with maximum dose 1 mg per kg per hour with intravenous PCA. lasting 8 hours after surgery.
Category
Treatment - Drugs
3
Description
Ketorolac controlling pain after laparatomy surgery (cholecystectomy).with maximum dose1 mg per kg withintravenous PCA.lasting 8 hours after surgery