This study will be done with aim to comparative investigation of Gabapentin, Ketamine, Entonox and Dexmedetomidine drugs effect on controlling pain of burn patients.This study is a double-blind clinical trial.The study population will included all patients referred to burn care of Imam Khomeini hospital in Kermanshah city.Inclusion criteria will included: Burn with grade 2 and 3, burns 20 percent to 50 percent and
Exclusion criteria will included: pregnant women, people with any chronic mental illness
A total of 100 persons will selected and randomly will assigned into four experiment groups .The first group will receive 1800 mg Gabapentin orally 2 hours before entering the operating room.In the second group ketamine in the form of intravenous in amount of 0.1 to 0.5 mg per kg of body weight will be given one minute before the start of surgery.The third group will receive Dexmedetomidine drug in the form of intravenous infusion and 0.1 to 0.5 mg per kilogram of body weight per minute in ten minutes before the start of surgery and in the fourth group five minutes before the start of surgery, Nitrous Oxidemixed with70% oxygen through a face mask is prescribed. Each group will receive serum and oxygen through a face mask during surgery. Beginning of the study, half an hour, an hour, two hours, four hours, six hours after surgery vital signs, nausea and vomiting and the pain of four groups patients using the visual analogue scale is measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605171310N10
Registration date:2016-10-13, 1395/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-13, 1395/07/22
Registrant information
Name
Alireza Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2670
Email address
info-jivr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2017-04-09, 1396/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Gabapentin, Ketamine, Entonox and Dexmedetomidine drugs in controlling pain of burn patients
Public title
Comparison the effectiveness of burn drugs on controlling pain of burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 60 years; Burn with grade 2 and 3, burns 20 percent to 50 percent; AS A Class 1 and 2
Exclusion criteria: pregnant women; People with any known chronic mental illness; Patients with history of chronic underlying cardiac, lung and kidney disease; patients treated with certain medications such as immunosuppressive medications or chemotherapy or Corticosteroid
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
kums.rec.1395.258
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T20
ICD-10 code description
Burn and corrosion
Primary outcomes
1
Description
The amount of pain
Timepoint
Beginning of the study, half an hour, an hour, two hours, four hours, six hours after start of surgery
Method of measurement
Using visual analogue scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 1800 mg Gabapentin orally 2 hours before entering the operating room.
Category
Treatment - Drugs
2
Description
In the second intervention group ketamine in the form of intravenous in amount of 0.1 to 0.5 mg per kg of body weight will be given one minute before the start of surgery.
Category
Treatment - Drugs
3
Description
The third intervention group will receive Dexmedetomidine drug in the form of intravenous infusionand 0.1 to 0.5 mg per kilogram of body weight per minute in ten minutes before the start of surgery
Category
Treatment - Drugs
4
Description
In the fourth intervention group five minutes before the start of surgery,Nitrous Oxide mixed with70% oxygen through a face mask is prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeyni Hospital
Full name of responsible person
Simin Chaghazardi
Street address
Emam Khomeyni Hospital, Naghliyeh Street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behroz Hamzeh
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Simin Chaghazardi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Naghliyeh Street
City
Kermanshah
Postal code
Phone
+98 83 3727 9104
Fax
Email
siminchaghazardi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Ali Reza Ahmadi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Naghliyeh Street
City
Kermanshah
Postal code
Phone
+98 83 3727 9104
Fax
Email
ahmadiar1012@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Simin Chaghazardi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Naghliyeh Street
City
Kermanshah
Postal code
Phone
+98 83 3727 9104
Fax
Email
siminchaghazardi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)