This is a single blind randomized clinical trial which will be done on trauma patients admitted to the emergency room of Imam Khomeini Hospital, Sari. The patient is not aware of drugs' type and dosage and just the person performing the procedure will know.Patients were randomly allocated (using a random number table) in two groups. The first group received 0.5mg/kg propofol and 1 µg/kg fentanyl and the second group received 0.5 mg/kg propofol and 1 mg/kg ketamine that will be administered through a peripheral vein with a no.20 catheter.Sample size was calculated 66 in each group.Every patient will be monitored by the author in 0, 5, 15 and 30 minutes after drug administration in account of sedation rate, pain rate and drugs complications. Data was recorded in each patient's data form. Recovery time and the need for additional doses also will be recorded.sedation rate is classified by the joint commission(TJC).Pain is rated according to numerical scale 0 to 10. All obtained data will be analyzed using SPSS 17.0. Appropriate Central and peripheral scattering indicators will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112224606N2
Registration date:2016-12-07, 1395/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Hamed Aminiahidashti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
h.aminiahidashti@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-11-10, 1395/08/20
Expected recruitment end date
2017-05-10, 1396/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of propofol and fentanyl with propofol and ketamine in sedation and analgesia in trauma patients
Public title
Comparison of propofol and fentanyl with propofol and ketamine in sedation and analgesia in trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
1. Age between 18 and 60 years, have indicated a painful procedure and this treatment included painful reduction of dislocation and fractures can be done in an emergency.
2 Persons according to the American Society of Anesthesiologists Physical Status Classification (ASA) class 1 and 2 have
Exclusion criteria:
1 - persons under 18 years and above 60 years of age
2- people with Anesthesiologists Physical Status Classification (ASA) class more than two
3-people with kidney and liver disease
4-person with alcohol consumption
5-people addicted to drugs
6- pregnant and lactating women
7- those who have contraindications to the use of ketamine and propofol and fentanyl
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Jooybar treeway, Imam Square
City
Sari
Postal code
4815724971
Approval date
2016-11-16, 1395/08/26
Ethics committee reference number
IR.MAZUMS.REC.95.1555
Health conditions studied
1
Description of health condition studied
Lower limb injury - Upper limb injury
ICD-10 code
T13.9 -
ICD-10 code description
Unspecified injury of lower limb, level unspecified injury of NOS - Unspecified injury of upper limb , level unspecified injury of arm NOS
Primary outcomes
1
Description
sedation
Timepoint
Before intervention,5 minutes after intervention, 15minutes after intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
sedation rate is classified by the joint commission(TJC). Grade 1 (Minimal sedation): patients obey orders, but patient consciousness has been disrupted. Grade 2 (Moderate sedation): the patient wakes up in responding to touch and has a withdrawal reflex to pain. Grade 3 (Deep sedation): patient wakes up with recurrent painful stimulation and cannot keep his/her airway by own. Grade 4 (General anesthesia): patient not respond to repeated painful provocations and requires mechanical ventilation, and cardiovascular status can also be disrupted.
2
Description
Pain
Timepoint
Before intervention,5 minutes after intervention, 15minutes after intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
Pain is rated according to numerical scale 0 to 10, so 10 is the worst pain condition and 0 is no pain condition.
Secondary outcomes
1
Description
Oxygen Saturation
Timepoint
Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
Puls oxymeter
2
Description
Heart Rate
Timepoint
Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
number per minutes
3
Description
Respiratory rate
Timepoint
Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
number per minutes
4
Description
Blood pressure
Timepoint
Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
sphygmomanometer mmhg
5
Description
Vomiting
Timepoint
Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
Observation
6
Description
Sialorrhea
Timepoint
Before intervention, 5 minutes after intervention, 15 minutes after intervention, 30 minutes after intervention, 120 minutes after intervention
Method of measurement
Observation
Intervention groups
1
Description
Second group received 0.5 mg/kg propofol and 1 mg/kg ketamine
Category
Treatment - Drugs
2
Description
First group received 0.5mg/kg propofol and 1 µg/kg fentanyl
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeni Hospital
Full name of responsible person
Hamed Aminiahidashti
Street address
Amir mazandarani Bolivard
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for researche, Mazandaran University of Medical Siences
Full name of responsible person
Ahmadali Enayati
Street address
Vice chancellor for researche, Mazandaran University of Medical Siences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for researche, Mazandaran University of Medical Siences