Pain management is a crucial component in the care of the postoperative patient undergoing laparoscopy. Intravenous acetaminophen has been used for the treatment of acute pain. The aim of this clinical trial is to evaluate the analgesic efficacy and safety of preventive doses 2 g compared with 1 g of intravenous acetaminophen in control of postoperative pain in patients undergoing gynecologic laparoscopic surgery. This double-blind, randomized study is conducted in 92 healthy women aged 20–70 years who are randomized to 2 groups; IV acetaminophen 2g (study group; n=46) or IV acetaminophen 1g( control group; n=46) in100 mL normal saline each given as a 15-minute infusion 20 minute before the end of surgery. Postoperative pain is treated with intravenous meperidine or suppository diclofenac. Pain scores, analgesic consumption and any adverse effects are recorded in PACU and at 1, 2, 3, 6, 12, and 24 h after the operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312147013N5
Registration date:2014-02-20, 1392/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-20, 1392/12/01
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Preventive Analgesia of Two Different Doses Intravenous Paracetamol in Control of Pain after Gynecologic Laparoscopic Surgery
Public title
Effect of prophylactic 2 g paracetamol in reducing of postoperative pain after gynecologic laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I, II; scheduled for gynecologic laparoscopy; age 20-70 years. Exclusion criteria: laparatomy with laparoscopy; allergy to paracetamol; history of organ system dysfunction( cardiovascular, respiratory, liver, renal, ...); history of psychopathy; history of chronic pain syndrome; pregnancy.
Age
From 20 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
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
Vice Chancellor for Research,Tabriz university of Medical sciences
Street address
Vice chancellor for research, Tabriz University, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Approval date
2014-02-15, 1392/11/26
Ethics committee reference number
92187
Health conditions studied
1
Description of health condition studied
Acute postoperative pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Pain
Timepoint
PACU and at 1, 2, 3, 6, 12, and 24h postoperatively
Method of measurement
visual analogue scale (0= non to 10= severe pain) cm)
Secondary outcomes
1
Description
Postoperative analgesic consumption
Timepoint
PACU and during 24h postoperatively
Method of measurement
number and amount of medication by mg
Intervention groups
1
Description
In study group: paracetamol 2g into 100 ml normal saline whiten 15 min, 20 min before the end of operation is infused.
Category
Treatment - Drugs
2
Description
In control group: 1g paracetamol into 100 ml normal saline whiten 15 min, 20 min before the end of operation is infused.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Simin Atashkhoyi
Street address
Sought Artesh Street, Al-Zahra Hospital, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medicalُ Sciences
Full name of responsible person
Dr. Rashidi
Street address
Vice chancellor for research, Daneshgah Street, Tabriz
City
Tabriz
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, Tabriz University of Medicalُ 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Tabriz, Al-Zahra Hospital
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, Sought Artesh Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/Professor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)