Adjuvant drugs such as Gabapentin can reduce postoperative pain killer opioids dose. The aim of this study was to evaluate Pregabalin effect on post operative pain in mandibular fractures operations. In a double –blind clinical trial in60 patients during 2012-2013 years with mandibular fracture operation were divided randomly into two groups of 30 after obtaining the informed consent about Lyrica. Inclusion criteria were age between 20-60 years, candidate for Mandibular fracture operation and exclusion criteria were drug addiction, history of pain killer drugs, drug sensitivity and patient‘s lack of consent. One hour before anesthesia, Lyrica 300mg capsule was given with 50 ml water to the patients at the beginning in group A. In the operating room premedication were given with Fentanyl and Midazolam. Induction was performed with Propofol then Cis-atracurium were given and intubated. Anesthesia was continued with Total Intravenous Anesthesia method by Propofol and Remifentanil. Group B did not received capsule and had same method of anesthesia..
Reverse patients were extubated and sent to the recovery after surgery. Pain scoring by ruler ( Visual Analogue Scale) , level of analgesics consumption (Morphine or Pethidine) based on mg (VAS) over3 were registered to 24 hours at times 0, 2, 6, 12and24 after consciousness. The findings were analyzed and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202281772N10
Registration date:2013-09-12, 1392/06/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-12, 1392/06/21
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science - Research team of anesthesiology
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The preemptive effect of a single dose of Pregabalin (Lyrica 300) for post operative pain control after Mandibular fracture surgery
Public title
The preemptive effect of a single dose of Pregabalin (Lyrica 300) for post operative pain control after Mandibular surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: were age between 20-60 years; candidate for Mandibular fracture operation
exclusion criteria: were drug addiction; history of pain killer drugs; drug sensitivity and patient‘s lack of consent.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Street address
Faculty of medicine, Vice chancellor for research, Daneshghah street
City
Tabriz
Postal code
Approval date
2012-07-22, 1391/05/01
Ethics committee reference number
5/4/9277
Health conditions studied
1
Description of health condition studied
Fracture of mandible
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible
Primary outcomes
1
Description
pain
Timepoint
2, 6, 12, 24 o'clock postoperative
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
Analgesic drugs
Timepoint
2, 6, 12, 24 o'clock postoperative
Method of measurement
Milligram/ Dose
Intervention groups
1
Description
Using Lyrica 300mg capsule One hour before anesthesia, in the intervention group
Category
Treatment - Drugs
2
Description
Without taking Lyrica 300mg capsule One hour before anesthesia,in the control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza teaching Hospital
Full name of responsible person
Dawood aghamohammadi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Science - Research team of anesthesiology
Full name of responsible person
Mahain Seidhejazie
Street address
Third floor, Research team of anesthesiology, Faculty of Medicine, Daneshghah Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Science - Research team of anesthesiology
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
Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Research team of anesthesiology, Third floor, Faculty of Medicine, Daneshghah Street
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Research team of anesthesiology, Third floor, Faculty of Medicine, Daneshghah Street
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Third floor, Research team of anesthesiology, Faculty of Medicine, Daneshghah Street
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)