Comparison the effect of paracetamol and pethedine in reducing opioid consumption and pain scale in patients under gastrointestinal tract malignancies surgery.
Background:This study evaluated the degree of postoperative analgesia effects of paracetamol in patients with gastrointestinal malignancy surgery and consumption of narcotics in ICU(intensive care of unit). Inclusion criteria: patients who candidates for GI Malignancy surgery and admitted in ICU. Exclusion criteria: A history of sensitivity to paracetamol, kidney disease(end stage), liver disease or more than two times increase in the liver enzymes. 60 patients between 30 to 81 years old with gastrointestinal malignancy that admitted in ICU after surgery. Patients are randomly divided into two group of thirty. Patients in first group received max one grams(1gr) intravenous. Paracetamol according to weight every six hours(4gr/24h). In second groups patients received pethedine 0.5mg/kg up to 50mg. In both group patients received a fixed dosage of 35 mg pethedine according to their needs. Visual analog scare and hemodynamic parameters, nausea and vomiting evaluated before receiving of each dosage. This data recorded for three days every patients. This study evaluated paracetamol effect in decrease of pethedine consumption.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207283305N4
Registration date:2017-08-14, 1396/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-14, 1396/05/23
Registrant information
Name
Ebrahim Alijanpour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1228 0013
Email address
dralijanpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2012-07-05, 1391/04/15
Expected recruitment end date
2013-04-20, 1392/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of paracetamol and pethedine in reducing opioid consumption and pain scale in patients under gastrointestinal tract malignancies surgery.
Public title
Effect of paracetamol in gastrointestinal cancer surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I-III; patient whom candidates GI Malignancy surgery and are hospitalized in ICU ward after surgery.
Exclusion criteria: A History of sensitivity to paracetamol; kidney disease (end stage); liver disease or more than two times increase in the liver enzymes; severe malnutrition or dehydration; alcohol users; Recipients Recipients probensid, Salyslamyd or drugs that are induce liver enzymes.Severe drop in blood pressure during or after, severe dyspnea requiring respiratory support, severe thrombocytopenia, decreased level of consciousness.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study was double blinded.At sampling time Patient and information collector were not aware of which group they would be and patients randomly divided in 2 groups, base on their folder numbers. The study designer was inform about drugs administration.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2012-06-26, 1391/04/06
Ethics committee reference number
MUBABOL.REC.1391.6
Health conditions studied
1
Description of health condition studied
Gastrointestinal Malignancies
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach
2
Description of health condition studied
Gastrointestinal Malignancies
ICD-10 code
C17
ICD-10 code description
Malignant neoplasm of small intestine
3
Description of health condition studied
Gastrointestinal Malignancies
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
4
Description of health condition studied
Gastrointestinal Malignancies
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of oesophagus
Primary outcomes
1
Description
Reduce pain
Timepoint
Three days after surgery.
Method of measurement
VAS
Secondary outcomes
1
Description
Nausea & Vomiting
Timepoint
Three days after surgery
Method of measurement
Visual and questional
Intervention groups
1
Description
Intervention group: every 6 hours up to a maximum weight based on grams (total dose 24 h 4 grams) Paracetamol IV to receive. If a patient requires drug for pain or analgesic PRN 0.5mg/kg, up to a maximum ceiling of 35 mg to receive.
Category
Treatment - Drugs
2
Description
Control group: patients, 0.5mg/kg every 6 hours, up to a maximum of 50 mg analgesic receives and the need for additional drug fixed dose of 35 mg intravenously has analgesic.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Ebrahim Alijanpour
Street address
Shahid Ghasemi Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research Babol University of Medical Sciences
Full name of responsible person
Dr Aliakbar Moghadamnia
Street address
Vice-chancellor of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
dralijanpour@yahoo.com; ans_dep@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
dralijanpour@yahoo.com; ans_dep@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Ebrahim Alijanpour
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
dralijanpour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)