Background and Objectives: Post- Traumatic pain after maxillofacial fracture is one of the several factors that led to numerous complication and increases in morbidity.
Pre- emptive analgesia can help in controlling the pain via different mechanisms. This study intends to determine if this method could reduce post operative pain and complications as well as the amount of post operative analgesics requirements.
Design:Sixty patients With mandibular fracture who are candidate for open reduction with intra oral approach , will be recruited. Main inclusion criteria are patients under going open reduction with intra oral approach for mandibular fracture and main exclusion criteria are History of addiction , Seizure and psychopathic conditions.
After providing written consent form, they will be randomly divided into the two groups: study group will undergo pre- emptive analgesia (Amantadine capsule 100 mg), while the control group will receive placebo.
At the end of the study two groups will be compared in terms of pain and analgesic consumption at various times after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406201772N13
Registration date:2014-06-27, 1393/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-27, 1393/04/06
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
Vice Chancellor of Research / Tabriz Medical University
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-03-18, 1393/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preoperative single dose of oral Amantadine for acute and chronic post operative pain control in Mandibular fracture
Public title
post operative pain control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: age from 20 to 60 people who are going to have open reduction for mandibular fracture
Exclusion criteria : Addiction, Seizure, psychopathic conditions and refuse to participate.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical science , reseach ethical committee
Street address
Daneshghah street/ Tabriz university of medical science/Fuculty of Dentistry/ ethical committee
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
934
Health conditions studied
1
Description of health condition studied
post operative pain control
ICD-10 code
Y46.7
ICD-10 code description
Antiparkinsonism drugs
Primary outcomes
1
Description
Pain
Timepoint
0, 2, 4, 6, 12 and 24 hours after operation
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Opioid cosumption
Timepoint
0, 2, 4, 6, 12 and 24 hours after operation
Method of measurement
Total Dose
Intervention groups
1
Description
Control group: instead of Amantadine capsule, recived placebo before the operation
Category
Treatment - Drugs
2
Description
Intervention group received Amantadine capsule 100 mg, 1-2 hours before surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital/Tabriz
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/ Vice chancellor of reseach
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street/ Tabriz university of medical science/ Fuculty of medicin
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/ Vice chancellor of reseach
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Tabriz university of medical science/ Vice chancellor of reseach
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street/ Tabriz university of medical science/ Fuculty of medicin
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/ Vice chancellor of reseach
Proportion provided by this source
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 science/fuculty of medicin/ Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
associated Professor
Other areas of specialty/work
Street address
Daneshghah street/ Tabriz university of medical science//fuculty of medicin/ Anesthesiology Dept
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
Tabriz university of medical science/fuculty of medicin/ Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Daneshghah street/ Tabriz university of medical science/ Fuculty of medicin Tabriz
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
Tabriz university of medical science/fuculty of medicin/ Anesthesiology Dept
Full name of responsible person
Dawood Aghamohammadi
Position
Associated Professor
Other areas of specialty/work
Street address
Daneshghah street/ Tabriz university of medical science//fuculty of medicin/ Anesthesiology Dept
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)