The effect of ketamine in preventing propofol injection pain in patients who taking general anesthesia with propofol induction- A ranomized clinical trial
The goal of this investigation was the study of alleviating effect of ketamin on the propofol injection pain. 168 patients who were candidate for general anesthesia with propofol induction enrolled in the study. Patients with positive history of central neurological, cardiac, renal and hepatic disease were excluded. Patients assigned into 6 groups randomly group 1: received ketamin 0.1 mg/kg while a tourniquet had been applied 10 cm above the injection site and after 30 seconds tourniquet was released and propofol injected through a vein on the forearm Group 2: the same as group 1 but propofol injected through a vein on the dorsum of the hand. Group3: 0.1 mg/kg ketamin administered without tourniquet application after 30 seconds propofol injected through a vein on the forearm. Group 4: the same as group 3 but propofol injected through a vein on the dorsum of the hand. Group 5 and 6 were control groups when the propofol was injected without pre injection of ketamin through a vein on the forearm and dorsum of the hand respectively. The pain of propofol injection was scored by verbal response scoring system (VRS) for adult patient and Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) applied for patients under 12 years old.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302177093N4
Registration date:2013-12-22, 1392/10/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-22, 1392/10/01
Registrant information
Name
Mohsen Saber Moghadamranjbar
Name of organization / entity
North khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 4229 7069
Email address
sabermoghadam41@nkh-cms.ac.ir
Recruitment status
Recruitment complete
Funding source
North khorasan University Of Medical Sciences-Student Research Committee
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ketamine in preventing propofol injection pain in patients who taking general anesthesia with propofol induction- A ranomized clinical trial
Public title
The effect of ketamine in prevention of pain from propofol injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:ASA Class 1,2;Candidate Of General Anesthesia With Propofol Injection Exclusion Criteria : Epilepsy;Known Cardiovascular Disease; Known Neurological Disease;GCS<15;Sensitivity History;Opioid And Sedative Drug As Premedication
Age
From 2 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
168
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee Of North Khorasan University Of Medical Sciences
Street address
Deputy Of Research And Technology, Berenji Line, South Shariat
City
Bojnurd
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
90پ361
Health conditions studied
1
Description of health condition studied
propofol injection pain
ICD-10 code
Y48.1
ICD-10 code description
Parenteral anaesthetics
Primary outcomes
1
Description
propofol injection pain
Timepoint
During Drug Injection
Method of measurement
Verbal Response Scale
Secondary outcomes
empty
Intervention groups
1
Description
received ketamine 0.1 mg/kg while a tourniquet had been applied 10 cm above the injection site and after 30 seconds tourniquet was released and propofol injected through a vein on the dorsum of the hand .
Category
Treatment - Drugs
2
Description
received ketamine 0.1 mg/kg while a tourniquet had been applied 10 cm above the injection site and after 30 seconds tourniquet was released and propofol injected through a vein on the dorsum of the hand .
Category
Treatment - Drugs
3
Description
0.1 mg/kg ketamine administered without tourniquet application after 30 seconds propofol injected through a vein on the forearm.
Category
Treatment - Drugs
4
Description
0.1 mg/kg ketamine administered without tourniquet application after 30 seconds propofol injected through a vein on the dorsum of the hand.
Category
Treatment - Drugs
5
Description
propofol injected without pre injection of ketamine through a vein on the forearm.
Category
Other
6
Description
propofol injected without pre injection of ketamine through a vein on the dorsum of the hand.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Dr Sabermoghadam
Street address
Shahriar Street - Imam Ali Hospital
City
Bojnourd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
North Khorasan University Of Medical Sciences
Full name of responsible person
akaberi arash
Street address
Berenji Line, South Shariati
City
Bojnourd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
North Khorasan 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
North Khorasan University of Medical Sciences, Bojnurd, Iran
Full name of responsible person
Dr Sabermoghadam
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Ali Hospital, Shahriar Street,
City
Bojnurd
Postal code
Phone
+98 58 4229 6965
Fax
Email
sabermoghadam41@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences, Bojnurd, Iran
Full name of responsible person
Dr Sabermoghadam
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Ali Hospital, Shahriar Street,
City
Bojnurd
Postal code
Phone
+98 58 4229 6965
Fax
Email
sabermoghadam41@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
North Khorasan University Of Medical Sciences
Full name of responsible person
Dr Sabermoghadam
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahriar street
City
Bojnourd
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)