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Comparison of analgesic effects of paracetamol and morphine infusion after elective laparotomy surgeries

Protocol summary

Summary
This is a double blind randomized trial to evaluate effects of intravenous paracetamol on postoperative pain control.Inclusion criteria are ASA I,II patients,age between 20 to 50 years old, elective laparotomy surgeries not more than 3h ,without any history of opium addiction, prolonged analgesic or sedative consumption, cardiac, pulmonary, thyroid or hepatic dysfunction,and allergy to morphine and paracetamol. exclusion criteria are serious disgusting complications such as nausea, vomiting or itching, no patient satisfaction of analgesic protocol and need to inject analgesic more than usual or severe hepatic or respiratory complications. total sample size is 112 . the trial intervention considered is intravenous infusion of morphine and paracetamol for postoperative pain management and the pain after surgery will be measured in different times . Nausea, vomiting and itching are secondary outcomes. recruitment duration time is about 18 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203114969N6
Registration date: 2012-04-09, 1391/01/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-04-09, 1391/01/21
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Tehran University of Medical Sciense
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
drpournajafian@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effects of paracetamol and morphine infusion after elective laparotomy surgeries
Public title
Comparison of analgesic effects of paracetamol and morphine infusion after elective laparotomy surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:1-ASA I,II patients, 2-age between 20 to 50 years old, 3- elective laparotomy surgeries, 4-duration of surgery less than 3h , 5-no opium addiction, 6- no history of prolonged analgesic or sedative consumption, 7- no history of cardiac or pulmonary disease, 8- no thyroid or hepatic dysfunction, 9- no history of allergy to morphine and paracetamol. exclusion criteria:1- serious disgusting complications such as nausea, vomiting or itching, 2- no patient satisfaction of analgesic protocol and need to inject analgesic more than usual, 3- severe hepatic or respiratory complications.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 112
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
Tehran University of Medical Science
Street address
Ghods st., Keshavarz blvd.
City
Tehran
Postal code
Approval date
2010-05-31, 1389/03/10
Ethics committee reference number
225

Health conditions studied

1

Description of health condition studied
Postoperative pain
ICD-10 code
------
ICD-10 code description
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Primary outcomes

1

Description
Postoperative pain
Timepoint
2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale from 1 to 10

Secondary outcomes

1

Description
Itching
Timepoint
During 24 hours after surgery
Method of measurement
Medical records and asking the patients

2

Description
Nausea and vomiting
Timepoint
During 24hours after surgery
Method of measurement
Medical records and asking the patients

Intervention groups

1

Description
Intravenous infusion of 20 mg morphin during 24 hours after surgery
Category
Treatment - Drugs

2

Description
Intravenous infusion of4 gr paracetamol during 24 hours after surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Alireza Pournajafian
Street address
Beh Afarin st., karim khan blvd.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciense
Full name of responsible person
Shohreh Asadi
Street address
Ghods st.,Kkeshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciense
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Alireza Pournajafian
Position
Assistant Professor
Other areas of specialty/work
Street address
Firoozgar Hospital, Beh Afarin st., karim khan blvd
City
Tehran
Postal code
1593748711
Phone
+98 21 8894 6762
Fax
+98 21 8894 2622
Email
a-Pournajafian@tums.ac.ir alipn78@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical science
Full name of responsible person
Alireza Pournajafian
Position
Assistant professor
Other areas of specialty/work
Street address
Firoozgar Hospital, Beh Afarin st., karim khan blvd
City
Tehran
Postal code
1593748711
Phone
+98 21 8894 6762
Fax
+98 21 8894 2622
Email
a-pournajafian@tums.ac.ir alipn78@yahoo.com
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
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