Comparison of efficacy and adverse events of ketamine-propofol(ketofol) with ketamine alone for procedural sedation and analgesia in emergency department
Objectives:
Ketamine is widely used for procedural sedation and analgesia in emergency department. Hypertension, nausea and vomiting and emergence reactions are frequently adverse events of Ketamine. Propofol is known as an effective drug for sedation in painful procedures. Respiratory depression is the most frequently adverse event of this drug. Due to Propofol doesn’t have analgesic effects, usually a combination of a short acting analgesic opioid is used with Propofol for procedural sedation and analgesia, which causes intensification respiratory depression in propofol. due to Ketamine is an analgesic drug, combination of these two drugs has been examined in several studies, but a number of studies with different doses and ratios of these two drugs is needed to confirm the efficacy and preference of this compound. In this study efficacy and adverse events of Ketamine and Propofol combination with Ketamine alone are compared.
Design:
randomized, double blind, phase 3 of trial
Setting and conduct:
Ketamine and Propofol combination (0.375 milligram per kilogram doses of either drug) and Ketamine alone (0.75 milligram per kilogram) Prescribed in two groups of 40 objects and adverse events record in questionnaire.
Inclusion and exclusion criteria:
patient should be Candidate for Procedural sedation and analgesia in emergency department, 18-60 age old, with score of 1 or 2 in physical status in American society of anesthesiologist classification and fasting at least for 3 hours.
Intervention:
Prescription of 0.075 milliliter per kilogram Ketofol or Ketamine
Main outcome measures:
Nausea or vomiting; recovery or procedural agitation; respiratory adverse events
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2014053117927N1
Registration date:2015-06-29, 1394/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-29, 1394/04/08
Registrant information
Name
Javad Hajizadeh Reineh
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3301 6692
Email address
j-hajizadeh@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Aja university of medical sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-01-14, 1393/10/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and adverse events of ketamine-propofol(ketofol) with ketamine alone for procedural sedation and analgesia in emergency department
Public title
Comparison of Ketofol with Ketamine for procedural sedation and analgesia in emergency department
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient should be Candidate for Procedural sedation and analgesia in emergency department (complicated laceration repair, abscess incision and drainage, closed joint reduction); Adult patient (should be in age range of 18 and more and 60 and less); Patient should be with score of 1 or 2 in physical status in American society of anesthesiologist classification; If it is not the urgency procedures patient should be fasting at least for 3 hours; Any other drugs except the study drugs (such as opioids or sedatives) shouldn't be prescribed to the patient prior to the study; Patient shouldn't have the Known allergy to Ketamine or any component of the formulation; Patient shouldn't have the Known allergy to Propofol or any component of the formulation (Egg and Soya); Patient shouldn't suffer from the illnesses which have high Intracranial pressure or the illnesses which having high Intracranial pressure is dangerous, such as (intracranial tumor, subdural hematoma, Head injury, Hydrocephalus ); Patient shouldn't suffer from the open eye injuries and eye diseases ( glaucoma, etc) in which the intraocular pressure is dangerous; Patient shouldn't suffer from Known aneurysm; Patient shouldn't have the history of co-existing psychotic disease such as schizophrenia and epilepsia; Patient shouldn't be pregnant.
Exclusion criteria
The patient or his attendant don't sign printed informed consent form.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
simple random sampling (the first patient in the control group, the second patient in the intervention group, the third patient in the control group and so on until the last patient)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja university of medical sciences
Street address
Aja university of medical sciences, Shahid Etemadzadeh St, westerly shahid Fatemi St
City
Tehran
Postal code
Approval date
2014-02-10, 1392/11/21
Ethics committee reference number
9222
Health conditions studied
1
Description of health condition studied
Dislocation of elbow
ICD-10 code
S53.1
ICD-10 code description
Dislocation of elbow
2
Description of health condition studied
Dislocation of shoulder joint
ICD-10 code
S43.0
ICD-10 code description
Dislocation of shoulder joint
3
Description of health condition studied
Dislocation of radial head
ICD-10 code
S53.0
ICD-10 code description
Dislocation of radial head
4
Description of health condition studied
Dislocation of wrist
ICD-10 code
S63.0
ICD-10 code description
Dislocation of wrist
5
Description of health condition studied
Dislocation of toe(s)
ICD-10 code
S93.1
ICD-10 code description
Dislocation of toe(s)
6
Description of health condition studied
laceration repair
ICD-10 code
ICD-10 code description
7
Description of health condition studied
Dislocation of ankle joint
ICD-10 code
S93.0
ICD-10 code description
Dislocation of ankle joint
8
Description of health condition studied
removal of pins
ICD-10 code
Z47.0
ICD-10 code description
Follow-up care involving removal of fracture plate and other internal fixation device
9
Description of health condition studied
repair of open wound of finger with damage to nail
ICD-10 code
S61.1
ICD-10 code description
Open wound of finger(s) with damage to nail
Primary outcomes
1
Description
nausea and/or vomiting
Timepoint
From drug prescription up to get needed criteria to leave the recovery
Method of measurement
The frequency of nausea and/or vomiting; record in questionnaire
2
Description
Procedural agitation
Timepoint
During the procedure to just before starting the recovery
Method of measurement
Base on physician’s judge; Patient interferes with the procedure or/and shows unusual reactions to painful manipulation despite enough doses of drug; record in questionnaire
3
Description
Recovery agitation
Timepoint
From the beginning of recovery to get required criteria to leave the recovery
Method of measurement
Base on physician’s judge; excessive excitement, arousal and agitation in the form of crying, hallucinations can be seen; record in questionnaire
4
Description
respiratory adverse events
Timepoint
From drug prescription up to get needed criteria to leave the recovery
Method of measurement
Based on Quebec criteria; record in questionnaire
Secondary outcomes
1
Description
efficacy
Timepoint
From drug prescription up to end of the procedure
Method of measurement
Efficacy in this study is defined 1) recall the events during the procedure in unpleasant way 2) patient doesn't experience the adverse events which cause unfinished procedure, permanent complication or unplanned admission to hospital.3)patient doesn't resist actively against the procedure and record in questionnaire.
2
Description
heartbeat rate
Timepoint
every minutes, 3 minutes before injection to achieve the required criterion for exiting the recovery
Method of measurement
Heartbeat rate in per minute shown by monitoring with the brand called Sa'adat; record in questionnaire
3
Description
blood pressure
Timepoint
3 minutes before injection, a minute after injection and per 4 minutes after injection to achieve the required criterion for exiting the recovery
Method of measurement
amount of blood pressure Based on millimeters of mercury shown by monitoring with the brand called Sa'adat; record in questionnaire
4
Description
The onset of medication to achieve adequate depth of sedation
Timepoint
The start of injection to achieve a Ramsay sedation score of 5 or more
Method of measurement
The duration of sedation score 5 or more is achieved. the sedation score should be announced per minute to end of the procedure; record in questionnaire
5
Description
recovery time
Timepoint
From last dose drug prescription up to get needed criteria to leave the recovery
Method of measurement
Base on Aldrete scale; minimum score of 8, with a minimum of 2 in respiratory and oxygen saturation; every minute; record in questionnaire
6
Description
Muscular rigidity
Timepoint
From drug prescription up to end of the procedure
Method of measurement
Base on physician’s judge; record in questionnaire
Intervention groups
1
Description
Intervention group: First the concentration of Ketamine(produce by hameln pharmaceuticals gmbh) should be diluted to 10 milligram per milliliter and then combine 5 milliliter of that with 5 milliliter of Propofol ( 10 milligram per milliliter produced by B Braun company) in a syringe. Sedation should start with an initial dose of .075 milliliter per kilogram Ketofol (0.375 milligram per kilogram Ketamine, 0.375 milligram per kilogram Propofol) in 30 seconds. One minute after the initial dose and per minute subsequent after that patient's level of sedation be measured according to Ramsay sedation scale. When the Ramsay sedation levels 5 or 6 achieve, the procedure will begins. If the physician diagnoses the sedation level is not properly (less than 5 Ramsay score) 0.0375 milliliter per kilogram ketofol (0.188 milligram per kilogram of either Ketamine and propofol ) is prescribed and after a minute procedure will begins if the sedation level is proper. Information will record in questionnaire.
Category
Treatment - Drugs
2
Description
Control group : First the concentration of Ketamine(hameln pharmaceuticals GmbH) should be diluted to 10 milligram per milliliter. sedation is prescribed with initial dose of 0.075 milliliter per kilogram Ketamine(0.75 milligram per kilogram) in 30 seconds. One minute after the initial dose and per minute subsequent after that patient's level of sedation is measured according to Ramsay sedation scale. When the Ramsay sedation levels 5 or 6 achieve ,the procedure will begins. If the physician diagnoses the sedation level is not properly (less than 5 Ramsay score) 0.0375 milliliter per kilogram Ketamine(0.375 milligram per kilogram) is prescribed and after a minute procedure will begins if the sedation level is proper. Information will record in questionnaire.