The objective of this randomized prospective, double-blind trial is to investigate Ketofol versus midazolam/fentanyl for procedural sedation and analgesia in the emergency department. Two set of syringes containing the drug dosage required for each 10 kg body weight were prepared by a certified anesthesiologist who did not participate in the collection of data. Ketofol syringes prepared as a 1:1 mixture of ketamine (7.5 mg) and propofol (7.5 mg) was used in group Ketofol (KF) (n = 31), and midazolam 0.4 mg + fentanyl 20 µg, in midazolam/fentanyl group (MF; n = 31). All syringes were covered with aluminum foil and were prepared to look the same. The study drugs with aforementioned dosage were given slowly over 1 minute as an initial dosage. Sedation endpoint was the comfort of the patients, with a variable degree of sedation allowing safe execution of the procedure without any pain suffering. If the patient exhibited grimacing and/or extremity movement requiring restraint, the procedure was withheld. Additional drug was then administered again in half of the last used dosage until little or no patient movement and/or grimacing occurred with the advancement of the procedure. Patient’s satisfaction, recovery time, and side effects are measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009204784N1
Registration date:2010-11-28, 1389/09/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-28, 1389/09/07
Registrant information
Name
Reza Shariat Moharari
Name of organization / entity
Sina hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 6883
Email address
moharari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2008-12-30, 1387/10/10
Expected recruitment end date
2009-06-30, 1388/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ketofol versus midazolam/fentanyl for Procedural Sedation and Analgesia in the Emergency Department: a Randomized, Prospective, Double-Blind Trial
Public title
Ketofol versus midazolam/fentanyl for Procedural Sedation and Analgesia in the Emergency Department: a Randomized, Prospective, Double-Blind Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients requiring PSA for mainly orthopedic procedures in the ED
Exclusion criteria: American Society of Anesthesia (ASA) physical status ≥ 3; a history of adverse reaction to Ketamine, Propofol, Midazolam, Fentanyl or egg; pregnancy; increased intracranial pressure; multiple trauma and psychiatric diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
31
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
Tehran University of Medical Sciences
Street address
Imam khomeini Hospital
City
Tehran
Postal code
Approval date
2007-04-30, 1386/02/10
Ethics committee reference number
4276 س/253741
Health conditions studied
1
Description of health condition studied
orthopedic procedures in the ED
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation
Timepoint
before and after procedure
Method of measurement
Ramsay Sedation Score
2
Description
Severity of Pain
Timepoint
before and after procedure
Method of measurement
VAS
Secondary outcomes
1
Description
Blood pressure
Timepoint
before and after procedure
Method of measurement
checking blood pressure (non invasive)
2
Description
practitioner’s satisfaction.
Timepoint
after the procedure
Method of measurement
Physician’s satisfaction ratings were recorded on a Visual Analog Scale (VAS), with 0= “very unsatisfied” and 10 = “completely satisfied”. Pain intensity was assessed by using a 10-cm VAS, with 0 = “no pain” and 10 = “worst possible pain.”
3
Description
Arterial oxygen saturation
Timepoint
before and after procedure
Method of measurement
pulse oximetry monitoring
4
Description
Heart rate
Timepoint
before and after procedure
Method of measurement
checking the pulse for one minute
5
Description
side effects of prescribed drugs
Timepoint
before, during and after procedure
Method of measurement
observation
Intervention groups
1
Description
A single dose of Midazolam, 0.03mg/kg, IV as well as Phentanyl, 2 microgram/kg, IV, 3 minutes before the procedure. The next doses will be administered with half dose, if needed
Category
Treatment - Drugs
2
Description
A single dose of Propofol, 1mg/kg, IV as well as Ketamine 1mg/kg, 2 microgram/kg, IV, 1.5 minutes before the procedure. The next doses will be administered with half dose, if needed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Imam Hospital
Full name of responsible person
Reza Shariat Moharari
Street address
Anesthesiology Department, Sina hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Keshavarz Blvd., Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Reza Shariat Moharari
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Department, Sina Hospital,
City
Tehran
Postal code
Phone
+98 911 331 2758
Fax
Email
moharari@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Shariat Moharari
Position
Associate Professor
Other areas of specialty/work
Street address
Sina hospital, Imam Khomeini Ave., Tehran
City
Tehran
Postal code
Phone
+98 911 331 2758
Fax
Email
moharari@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Reza Shariat Moharari
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
moharari@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)