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Comparison of the analgesic effect of intravenous paracetamol combind meperidine and mepridine alone after elective caesarean

Protocol summary

Summary
In this study, 70 pregnant women, ASA I, II, candidate for Repeat II elective Caesarean Section, are randomized into two equal groups. Cesarian section is performed by spinal anesthesia with 60mg Lidocaine 5% .The control group receives 25 mg meperidine plus 6 ml intravenous normal saline15 minutes before the end of surgery.The intervention group receives 25 mg meperidine and 6 ml (1 gram) intravenous Paracetamol 15 minutes before the end of surgery. Then control group receives 6 ml intravenous normal saline and intervention group 6 ml (1 gram) intravenous Paracetamol every 6 hours in 6,12,18 hours. At any time if the patient's pain score greater than 4 based on visual criteria, meperidine 25 mg IV is injected. Time of first dose and the total amount of meperidine administered within 24 hours is recorded. Side effects including nausea, vomiting, itching, respiratory depression , dizziness and headaches are recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203117752N4
Registration date: 2012-05-23, 1391/03/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-23, 1391/03/03
Registrant information
Name
Parviz Amri Maleh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
pamrimaleh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research- Babol University of Medical science
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of intravenous paracetamol combind meperidine and mepridine alone after elective caesarean
Public title
Comparison of the analgesic effect of intravenous paracetamol combind meperidine and mepridine alone after elective caesarean
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Pregnant women , 18-40 years, class I,II America Society of Anesthesiology; Elective repeat II cesarean section with spinal anesthesia . Exclusion criteria: patients who are taking narcotic and analgesic, contraindication for intravenous meperedineor paracetamol ,history of alcoholism or uncontrolled consumption of a drug. emergency cesarean surgery,duration of surgery more than an hour,Prescribed narcotic or other drugs because of inadequate levels of the spinal anesthesia
Age
From 18 years old to 40 years old
Gender
Female
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)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice-chancellor of research of Babol University of Medical Sciences
Street address
Gangafrooz St, Babol University of Medical Sciences
City
Babol
Postal code
4717641367
Approval date
2012-02-28, 1390/12/09
Ethics committee reference number
30/5895/39/ژ/پ

Health conditions studied

1

Description of health condition studied
Elective cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
pain
Timepoint
24 hours
Method of measurement
Visual Analog Scale

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group 1 gr. IV Acetaminophen administrate 15 min. before end of surgery and Q6hours to 24 hours.
Category
Treatment - Drugs

2

Description
In control group, Iv meperidine 25 mg administrate 15 min. before end of surgery and Q6hours to 24 hours.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rohani teaching Hospital
Full name of responsible person
Amri, Parviz
Street address
Gangafrooz St, Rohani teaching Hospital
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research of Babol University of Medical Sciences
Full name of responsible person
Mostafazadeh, Amrolah
Street address
Babol,Gangafrooz St, ,Babol University of Medical Science
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 for research of 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
Amrimaleh, Parviz
Position
Anestesiologist, FCCM
Other areas of specialty/work
Street address
Gangafrooz St, Rohani teaching Hospital
City
Babo
Postal code
4717641367
Phone
+98 11 1223 8296
Fax
Email
pamrimaleh@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
Amrimaleh, Parviz
Position
Anestesiologist, FCCM
Other areas of specialty/work
Street address
Gangafrooz St, Babol University of Medical Sciences
City
Babol
Postal code
47176
Phone
+98 11 1223 8296
Fax
Email
pamrimaleh@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
Amrimaleh, Parviz
Position
Anestesiologist, FCCM
Other areas of specialty/work
Street address
Gangafrooz St, Babol University of Medical Sciences
City
Babol
Postal code
4717641367
Phone
+98 11 1223 8296
Fax
+98 981112238296
Email
pamrimaleh@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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