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The effect of preemptive analgesia with (Gabapentine, Celecoxib, Acetaminophen) on pain and anxiety score after femoral fractures surgery

Protocol summary

Summary
(1) Objectives: evaluate the effect of three pre- drug combinations of gabapentin , celecoxib , and acetaminophen in reducing anxiety, pain , need for postoperative morphine consumption and side effects in adult patients were Distal femoral fracture surgery plating. (2) Design: Randomized controlled trial. (3) Setting and conduct: Sample size of 100 patients will randomly assign into intervention (preemptive analgesia) or control (placebo) group and will be treated in academic orthopedic hospital. (4) Inclusion criteria: age between 25 to 45 years, ASA versus I and II. Exclusion criteria: failure of spinal anesthesia or if take more than 90 minutes. (5) Interventions: one hour before surgery, under the direct supervision of a nurse who was unaware of the status of drug or placebo to patients three oral gabapentin (600 mg dose), celecoxib (200 mg dose) and acetaminophen (500 mg dose) plus 50cc water is fed to the case group and control group given a placebo. (6) Main outcome measures: Primary outcome is VAS score of pain which will be assessed at 1, 2, 3, 4, 8 and 12 hour after surgery, the first analgesic request after resolution of spinal anesthesia, opioid consumption and respiratory rate, pulse oximetry, heart rate, blood pressure and other side effects mentioned temporal resolution within 24 hours checked, STAI anxiety criteria.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014051417681N1
Registration date: 2014-05-30, 1393/03/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-30, 1393/03/09
Registrant information
Name
Mehran Soleymanha
Name of organization / entity
Guilan University of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 13 1722 3300
Email address
soleymanha_m@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan university of medical sience
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preemptive analgesia with (Gabapentine, Celecoxib, Acetaminophen) on pain and anxiety score after femoral fractures surgery
Public title
The effect of preemptive analgesia on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients candidates for surgery under spinal anesthesia plating of distal femur; aged between 25 to 45 years;patient satisfaction; ASA (American Society of Anesthesiologisisclass I and II) Exclusion criteria: presence of underlying conditions (such as diabetes) or organ failure; history of drug or alcohol addiction; history of cardiovascular problems or heart stroke; history of allergy to opioids and gabapentin and celecoxib; renal dysfunction; multiple trauma; obesity (BMI greater than 35); pathologic fractures; and people that receive housing long time for any reason.
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee, Guilan University of Medical Sciences
Street address
Research vice-chancellor of Guilan university of medical sciences building, Shahid Beheshti blv.
City
Rasht
Postal code
Approval date
2014-03-10, 1392/12/19
Ethics committee reference number
1920452606

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety

2

Description of health condition studied
pain
ICD-10 code
Z09.4
ICD-10 code description
Follow-up examination after treatment of fracture

Primary outcomes

1

Description
pain
Timepoint
1,2,3,4,8,12 houres after surgery
Method of measurement
vas score

2

Description
anxiety
Timepoint
1,2,3,4,8,12 houres after surgery
Method of measurement
STAI

Secondary outcomes

empty

Intervention groups

1

Description
One hour before surgery, are given a placeboto control group patients.
Category
Placebo

2

Description
one hour before surgery , three-dose oral gabapentin 600 mg, celecoxib 200 mg and 500 mg of acetaminophen with 50 cc of water is fed to case group patients
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Mehran Soleymanha
Street address
Parastar Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Dr. Abdolrasoul Sobhani, Research chancellor of Guilan university of medical science
Street address
Research vice-chancellor of Guilan university of medical sciences building, Shahid Beheshti blv.
City
Rasht
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, 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 Science
Full name of responsible person
Dr Mehran Soleymanha
Position
Assistant Professor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
Phone
+98 13177223300
Fax
+98 13 1722 3311
Email
soleymanha_m@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Dr Mehran Soleymanha
Position
Assisstant Professor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
Phone
+98 13 1722 3300
Fax
+98 13 1722 3311
Email
soleymanha_m@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Mehran Soleymanha
Position
Assistant Professor
Other areas of specialty/work
Street address
Poursina Hospital, Parastar st.
City
Rasht
Postal code
Phone
+98 13 1722 3300
Fax
+98 13 1722 3311
Email
soleymanha_m@gums.ac.ir dr_msoleimanha@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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