Objectives: To compare Fentofol (Fentanyl+Propofol) with Ketofol (Ketamine+ Propofol) for performing painful procedures in the emergency department regarding achievement of Aldret score of 12 (which indicates that the patient can be transferred out of the cardiac monitoring area safely).
Inclusion criteria: All patients over 16 years of age for whom a painful procedure needs to be performed in the emergency department will be included in the study.
Exclusion criteria: presence of any co-morbidity (ASA score more than 1); procedure needs to be done in the operating room; Spo2 less than 92%; systolic blood pressure less than 100mmg; GCS (Glasgow coma scale) score less than 15.
Study population: A total of 192 patients will be enrolled in the study by convenience sampling. Patients will be randomized using simple randomization to Ketofol or Fentofol groups.
Intervention: depending of the study group, Fentanyl (1microgram/Kg by intravenous slow injection)+ propofol (1mg/Kg by intravenous slow injection) or Ketamine (1 mg/Kg by intravenous slow injection)+ propofol will be administered under standard procedural sedation condition. The dose may be repeated at the discretion of the physician in charge of the patient to perform the procedure safely and without marked pain or resistance by the patient. The patient and the investigator are blinded to the administered drug combination. َAfter the end of the procedure, the Aldret score will be calculated each minute until the patient reaches the score of 12; this is the point when the time measurement stops.
Primary outcome: Time to achieve the Aldret score of 12 in minutes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016050615941N4
Registration date:2017-09-11, 1396/06/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-11, 1396/06/20
Registrant information
Name
Amirhossein Mirafzal
Name of organization / entity
Kerman University of Medical sceinces
Country
Iran (Islamic Republic of)
Phone
+98 34 1247 4638
Email address
mirafzal@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2017-10-01, 1396/07/09
Expected recruitment end date
2018-05-01, 1397/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Fentofol with Ketofol to achieve the Aldret score of 12 in painful procedures in the emergency department
Public title
Fentofol vs. Ketofol for painful procedures in the emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients over 16 years of age for whom a painful procedure needs to be performed in the emergency department.
Exclusion criteria: presence of any co-morbidity (ASA score more than 1); procedure needs to be done in the operating room; Spo2 less than 92%; systolic blood pressure less than 100mmg; GCS (Glasgow coma scale) score less than 15; patient refusal to participate
Age
From 16 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
192
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
Kerman University of Medical Sciences
Street address
Faculty of medicine, Kerman University of Medical Sciences
City
Kerman
Postal code
Approval date
2015-05-10, 1394/02/20
Ethics committee reference number
IR.KMU.REC.1394.220
Health conditions studied
1
Description of health condition studied
Painful procedures in the emergency department
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
time to achieve the Aldret score of 12
Timepoint
after the procedure ended
Method of measurement
counting minutes after the beginning of drug administration
Secondary outcomes
1
Description
adverse reactions
Timepoint
during and after the procedure
Method of measurement
recording any adverse reactions attributable to the drugs
Intervention groups
1
Description
Arm 1: Intervention name: Fentofol (Fentanyl+ Propofol)
Intervention description: Fentanyl (1 microgram/Kg by slow intravenous injection) and Propofol ( 1 milligram/Kg by slow intravenous injection) are administered in separate 5 ml syringes with a number assigned to the drugs. The patients and the investigator are blinded to the drugs in the syringe. if needed, the same doses are repeated to achieve appropriate sedation and analgesia and the total dose will subsequently be calculated. After the end of the procedure, the Aldret score will be calculated each minute until the patient reaches a score of 12, at which point the time measurement ends.
Category
Treatment - Drugs
2
Description
Arm 2: Intervention name: Ketofol (Ketamine+ Propofol)
Intervention description: Ketamine (1milligram/Kg by slow intravenous injection) and Propofol ( 1 milligram/Kg by slow intravenous injection) are administered in separate 5 ml syringes with a number assigned to the drugs. The patients and the investigator are blinded to the drugs in the syringe. if needed, the same doses are repeated to achieve appropriate sedation and analgesia and the total dose will subsequently be calculated. After the end of the procedure, the Aldret score will be calculated each minute until the patient reaches a score of 12, at which point the time measurement ends.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Academic Hospital
Full name of responsible person
Amirhossein Mirafzal
Street address
Gharani St., Bagh-e-Melli Crossway
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrad Tajaddini (investigator)
Full name of responsible person
Shahrad Tajaddini
Street address
Bahonar Academic Hospital, Gharani St.,
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrad Tajaddini (investigator)
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
Kerman University of Medical Sciences
Full name of responsible person
Amirhossein Mirafzal
Position
Assistant professor of emergency medicine
Other areas of specialty/work
Street address
Bahonar Hospital, Gharani St.,
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
a.mirafzal@yahoo.com- mirafzal@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of edical Sciences
Full name of responsible person
Shahrad Tajaddini
Position
Assistant professor of emergency medicine
Other areas of specialty/work
Street address
Bahonar Hospital, Gharani St.,
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
tajadinishahrad@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of edical Sciences
Full name of responsible person
Amirhossein Mirafzal
Position
Assistant professor of emergency medicine
Other areas of specialty/work
Street address
Bahonar Hospital, Gharani St.,
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
a.mirafzal@yahoo.com- mirafzal@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)