A comparison of the analgesic effect of intravenous fentanyl and acetaminophen in treatment of postoperative pain lower extremity orthopedic problems in patients referred to Poursina hospital during the year 1391
The aim of the study:
A comparison of the analgesic effect of intravenous fentanyl and acetaminophen in treatment of postoperative pain lower extremity orthopedic problems in patients referred to Poursina hospital during the year 1391
Study design: randomized, not blinding, no placebo-controlled, single-center.l
Study population:
Inclusion criteria: candidate male for interlock surgery in closed fracture of tibia and fibula without smashing or segmented
Exclusion criteria: patients with severe respiratory, liver and kidney problems, increased intracranial pressure (High ICP), sensitivity to acetaminophen, surgical problems, anesthesia interventions and complications during surgery
Sample size: 114 patients
Study intervention/ interventions: injection of 500 microgram vial of fentanyl, which is being built by Abu Reyhan company, receiving 1500 micrograms of it over 24 hours. ( has been made 250ml with normal saline)
Intervention time: After the surgery the patient returned to the recovery unit
Primary outcome : pain control
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122611898N1
Registration date:2013-02-14, 1391/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-14, 1391/11/26
Registrant information
Name
Ahmadreza Mirbolouk
Name of organization / entity
Guilin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 2250
Email address
ah.mirbolouk@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Guilan University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the analgesic effect of intravenous fentanyl and acetaminophen in treatment of postoperative pain lower extremity orthopedic problems in patients referred to Poursina hospital during the year 1391
Public title
Analgesic effect in treatment of pain after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidate male for Interlock surgery in closed fracture of tibia and fibula without smashing or Segmented
Exclusion criteria: patients in the event of severe respiratory, liver and kidney problems, increased intracranial pressure (High ICP), sensitivity to acetaminophen, surgical problems, anesthesia interventions and complications during surgery
Age
From 25 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Namjoo Street, facing Azodi Stadium, headquarters of Guilan University of Medical Sciences
City
Rasht
Postal code
Approval date
2012-11-17, 1391/08/27
Ethics committee reference number
9110264805
Health conditions studied
1
Description of health condition studied
pain control
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain
Timepoint
After receiving drug at intervals 15.30, 45 minutes, 1, 2, 3, 4 and 5 hours
Method of measurement
Are examined through the pain score
Secondary outcomes
empty
Intervention groups
1
Description
1_In persons who receiving the apotel, 1 gr of the drug (1000 mgr in a vial) in 150ml saline solution and per 6 hours, infusion 1 mgr of the drug during 15 minutes are administered.
Category
Treatment - Drugs
2
Description
2_ Those receiving 500 microgram vial of fentanyl, which is being built by Abu Reyhan company, 1500 micrograms over 24 hours of receiving it. (has been made 250 ml with normal saline)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Mohammad Haghighi (MD)
Street address
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Department, Guilan University of Medical Sciences
Full name of responsible person
Rasoul Tabari (MD)
Street address
, ,Research and Technology Department, Guilan University of Medical Sciences, opposite of agriculture bank, Gas _ circle
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Department, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi (MD)
Position
Anesthesiologist /Associate of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
Rasht
Postal code
Phone
+98 13 1322 0306
Fax
Email
manesthesist@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi (MD)
Position
Anesthesiologist/Associate of guilan university of medical sciences
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
Rasht
Postal code
Phone
+98 13 1322 0306
Fax
Email
manesthesist@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Zinat Akbari
Position
Medical Student /participant
Other areas of specialty/work
Street address
City
Rasht
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)