Comparison of sedative and analgesic effects of ketamine-propofol and ketamine-sufentanil during bone marrow aspiration and lumbar Puncture in children
1. Determination and comparison of the average level of sedation (UMSS) studied in both groups during the procedure
2. Determination and comparison of the average intensity of pain (VAS) in the two study groups during the procedure
3. Determination and comparison of the average mean arterial pressure in the two groups before induction, during the procedure and recovery.
4. Determination and comparison of the average oxygen saturation in the two groups before induction, during and at the end of the recovery procedure.
5. Determination and comparison of the two groups in mean heart rate before induction, during and at the end of the procedure and recovery.
6. Determination and comparison of the onset of sedation in the two study groups.
7. Determination and comparison of the mean recovery time in the two study groups.
Design
Parallel group, double-blind clinical trial with the random numbers using two groups of 34 patients selected for therapeutic intervention
Settings and conduct
Double-blind study in which patients, pediatric hematologists and colleagues used data collected were not aware of the medications and is conducted at omid Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:children between 6 month and 14 years old Candidate for bone marrow aspiration and lumbar Puncture
Exclusion criteria:Hypersensitivity or allergic reaction to any medication regimen The use of analgesic and anesthetic in the past
Intervention groups
Intervention group: Group 1 (propofol-ketamine) 1 mg / kg propofol plus 0.3mg / kg ketamine were injected doubled
Intervention group: Group 2 (ketamine-sufentanil) 1mg / kg ketamine with 0.1mic / kg sufentanil were injected doubled
Main outcome variables
Compare the level of sedation and pain in both groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170809035601N6
Registration date:2018-07-18, 1397/04/27
Registration timing:retrospective
Last update:2018-07-18, 1397/04/27
Update count:0
Registration date
2018-07-18, 1397/04/27
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 2105
Email address
hamidshetabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2017-03-21, 1396/01/01
Trial completion date
empty
Scientific title
Comparison of sedative and analgesic effects of ketamine-propofol and ketamine-sufentanil during bone marrow aspiration and lumbar Puncture in children
Public title
analgesic effects of ketamine-propofol and ketamine-sufentanil
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children between 6 month and 14 years old
Candid bone marrow aspiration and lumbar Puncture
Exclusion criteria:
Hypersensitivity or allergic reaction to any medication regimen
The use of analgesic and anesthetic ago
Cardiovascular disease, respiratory disease, liver disease, epilepsy or a history of seizures, neurological disorders, brain tumor or metastasis.
There are chronic pain syndromes.
Head injuries
Age
From 6 months old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
68
Actual sample size reached:
68
Randomization (investigator's opinion)
Randomized
Randomization description
With the arrival of the patient to the operating room, randomly block (permuted block randomization) with 4 blocks each divided into 2 groups.The first group recipient will ketamine-propofol and the second group recipient will ketamine-sufentanil
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and pediatric hematologists and Fellow collecting information were not aware of the medications.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
hezar jarib
City
isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2016-08-15, 1395/05/25
Ethics committee reference number
IR.MUI.REC1395.3.643
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukaemia [ALL]
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
Sedation Level
Timepoint
During Procedure
Method of measurement
University of Michigan Sedation Scale (UMSS)
2
Description
Analgesia
Timepoint
During Procedure
Method of measurement
Universal Pain Assessment Tool (UPAT)
Secondary outcomes
1
Description
Hemodynamic changes ( Heart rate , Systolic and Diastolic blood pressure, Mean atria pressure)
Timepoint
Before and during the procedure and recovery time
Method of measurement
Cardiac monitoring and automatic blood pressure monitoring
2
Description
Arterial oxygen saturation
Timepoint
Before and during the procedure and recovery time
Method of measurement
Pulse oximeter
Intervention groups
1
Description
Intervention group: Group 1 (propofol-ketamine) 1 mg / kg propofol plus 0.3mg / kg ketamine were injected doubled
Category
Treatment - Drugs
2
Description
Intervention group: Group 2 (ketamine-sufentanil) 1mg / kg ketamine with 0.1mic / kg sufentanil were injected doubled
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
omid Hospital in Isfahan
Full name of responsible person
Hamidreza Shetabi
Street address
Khayyam Street, Kay Nahr Farshadi,omid Hospital
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3236 8005
Fax
Email
hamidshetabi@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nejatbakhsh DR
Street address
Hezar jerib , Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5555
Email
hamidshetabi@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sofe Bolvar , Al-Zahra Medical Center, Department of Anesthesia
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 3668 4510
Email
hamidshetabi@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sofe Bolvar , Al-Zahra Medical Center, Department of Anesthesia
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 3668 4510
Email
hamidshetabi@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sofe Bolvar , Al-Zahra Medical Center, Department of Anesthesia
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 3668 4510
Email
hamidshetabi@mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data include the amount of sedation and pain level and hemodynamic indicators and complications in both groups after the intervention of unrecognizable people sharing.
When the data will become available and for how long
Beginning 6 months after the publication access
To whom data/document is available
Academic researchers and health
Under which criteria data/document could be used
Used for research and therapeutic
From where data/document is obtainable
Email responsible for public accountability study :hamidshetabi@mui.ac.ir
What processes are involved for a request to access data/document
If access upon request via e-mail will be sent within a maximum 1 month