Determine the effect of preoperative intravenous acetaminophen administration on pain after surgery in patients with hip fracture
Design
Clinical trial with control group, Community based and pragmatic, with parallel group, double blind, Randomized with random number table
Sample size 66
Trial phase 3
Settings and conduct
This study will be performed in Sabzevar Shahid Beheshti Hospital. The participants were randomly divided into two groups of control and intervention. In the intervention group, intravenous acetaminophen and in the control group will be used normal saline as a placebo, then the pain level of the patients will be evaluate by visual analogue scale and the timing of the application of the first dose of the analgesic and the amount of the analgesic after the operation will be recorded.
Participants/Inclusion and exclusion criteria
Entrance condition:
All patient with hip fracture that have age over 15 years; Patient that have not concurrent any fracture; Patients that don't take any analgesic in 6 hour before surgery; Patients that don't have any concurrent surgery; Patients that have not aclocohol or drug abuse; Only patients that take general anesthesia; Patients that be in class 1 and 2 of American Anesthesiology Association
Condition of failure to enter:
Patients with hepatic failure; Patients with renal failure; Patient with history of drug allergy to IV Acetaminophen
Intervention groups
In intervention group patients receive15 mg/kg of intravenous acetaminophen half an hour before surgery.
In control group patients receive 10 cc of normal saline half an hour before surgery.
Effect of IV Acetaminophen on postoperative pain in patients with Hip fracture
Public title
Effect of iv Acetaminophen on pain in hip fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patient with hip fracture that have age over 15 years
Patient that have not concurrent any fracture
Patients that don't take any analgesic in 6 hour before surgery
Patients that don't have any concurrent surgery
Patients that have not aclocohol or drug abuse
Only patients that take general anesthesia
Patients that be in class 1 and 2 of American Anesthesiology Association
Exclusion criteria:
Patients with hepatic failure
Patients with renal failure
Patient with history of drug allergy to IV Acetaminophen
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study , with the help of random number table patients will be placed in the two of study group.
Blinding (investigator's opinion)
Double blinded
Blinding description
By the nurse of the operating room half an hour before surgery, intravenous acetaminophen will be given to group A and normal saline (placebo) by syringes similar to those of group A will be given to group B patients and patients will not be aware of the contents of the syringe. The evaluator The outcome will also evaluate the outcome without knowing the prescription drug for each group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Ethics committee of Sabzevar University of Medical Sciences, Shohadaye Hastei Blvd., Sabzevar City
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2018-02-18, 1396/11/29
Ethics committee reference number
IR.MEDSAB.REC.1396.139
Health conditions studied
1
Description of health condition studied
Hip fracture
ICD-10 code
S72
ICD-10 code description
Fracture of femur
Primary outcomes
1
Description
The clinical situation of pain
Timepoint
Half an hour after surgery, 4 hours after surgery, 12 hours after surgery and 24 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Iv Acetaminophen is a analgesic drug that in intervention group will be use one time ,half one hour before surgery and with dose 15 mg/kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital in Sabzevar city
Full name of responsible person
Mostafa Jafarpour
Street address
Shahid beheshti hospital, Razi ave., Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617748189
Phone
+98 51 4464 0115
Email
jafarpoorM90@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr.Fereshte ghorat
Street address
Research and technology Unit, Sabzevar University of medical sciense, Shodaye Hastei Blvd., Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
VCResearch@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Jafarpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ground Floor, The last southern house, Andishe 3 ave, Sabzevar City
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618614341
Phone
+98 51 4466 4378
Email
jafarpoorM90@medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Jafarpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ground Floor, The last southern house, Andishe 3 ave, Sabzevar City
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618614341
Phone
+98 51 4466 4378
Email
jafarpoorM90@medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mostafa Jafarpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ground Floor, The last southern house, Andisheh 3 ave, Sabzevar City
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618614341
Phone
+98 51 4466 4378
Email
jafarpoorM90@medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD