Comparative evaluation of the effect of the two combinations of Propofol-Ketamine and Propofol-Sufentanil on sedation and analgesia during painful diagnostic procedures in children with hematologic malignancies
Comparison of the effects of two combinations of propofol-ketamine and propofol-sufentanil on sedation and analgesia during painful procedures in children with hematologic malignancies.
Design
Double-blind clinical trial with parallel groups using random allocation software, patients will be included in two groups of 35 for treatment intervention.
Settings and conduct
After approval by the Ethics Committee of Isfahan University of Medical Sciences,
102 children with blood malignancies in Omid Hospital are scheduled for 1396
In this patient study, the pediatric hematologist and data collector are unaware of the grouping and drugs studied.
Participants/Inclusion and exclusion criteria
Children 1 to 14 years old with Hematologic malignancy, Acute lymphoblastic leukemia
Inclusion criteria: Children aged 1 to 14 years with Hematologic malignancy
Exclusion criteria: injury to the head
Cardiovascular disease, Respiratory disease, Liver disease,
Epilepsy, seizure, or neurological disorders
Use of analgesic or sedative medications before surgery
Chronic pain syndromes
Intervention groups
Propofol-sufentanil (PS) and Propofol-Ketamine (PK) are grouped. In the PK group, propofol 1 mg / kg at concentrations of 5 mg / cc and ketamine 0/3 mg / kg at a concentration of 5 mg / cc and in the ps group sufentanil 0 / 5mic / kg and propofol 1mg / kg at a concentration of 5mg / cc, the volume of the drug compounds to 20 cc, and the infusion of drugs continues to reach the appropriate sedation level.
Main outcome variables
Sedation level; Analgesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170809035601N9
Registration date:2018-10-23, 1397/08/01
Registration timing:retrospective
Last update:2018-10-23, 1397/08/01
Update count:0
Registration date
2018-10-23, 1397/08/01
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
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-04-05, 1396/01/16
Actual recruitment end date
2018-02-09, 1396/11/20
Trial completion date
2018-02-09, 1396/11/20
Scientific title
Comparative evaluation of the effect of the two combinations of Propofol-Ketamine and Propofol-Sufentanil on sedation and analgesia during painful diagnostic procedures in children with hematologic malignancies
Public title
Effect of propofol-ketamine and propofol-sufentanil on sedation and analgesia in painful diagnostic methods in children with hematological malignancies
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 1 to 14 years
Hematologic malignancies
Acute lymphoblastic leukemia
Exclusion criteria:
A recent trauma to the head
Cardiovascular, pulmonary, or liver diseases
Epilepsy, seizure or neurological disorder
Use of analgesic or sedative medications before surgery
Chronic pain syndrome
History of allergy to the drugs studied
Age
From 1 year old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
120
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in the operating room are divided into two groups by random allocation software (Random allocation software). The first group propofol, ketamine, and the second group will receive propofol, sufentanil
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, participants, the main investigator and the person collecting data are unaware of the grouping of patients and the type of medication.
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
Isfahan University of Medical Sciences, Hezar jerib Blvd
City
Isfahan
Province
Isfehan
Postal code
8174173461
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
Ir.mui.rec.1396.3.629
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
Secondary outcomes
1
Description
Analgesia
Timepoint
During procedure
Method of measurement
Universal Pain Assessment Tool
Intervention groups
1
Description
In the PK group, propofol 1mg / kg with 5mg / cc of vectamine (0 / 3mg / kg) with 5mg / cc concentration of drug was added to 20 cc and the infusion of the drug continued to reach the appropriate sedation level.
Category
Treatment - Drugs
2
Description
Control group: In the PS group, sufentanil 0.5mic / kg and propofol 1mg / kg at a concentration of 5mg / cc, the volume of the drug was added to 20 cc. Infusion of the drug compound continues to flush with the appropriate sedation level:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Medical Center
Full name of responsible person
Hamidreza Shetabi
Street address
Khayyam Street, Kay Nahr Farshad Hospital, Seyed Alshohada Hospital
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3236 8005
Email
hamidshetabi@med.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
Isfahan University of Medical Sciences, Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5555
Email
research@mui.ac.ir
Web page address
http://research.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
Alzahra Hospital, Sofe Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
hamidshetabi@med.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
Al-Zahra Medical Center, Department of Anesthesia, Sofe Bolvd
City
Isfahan
Province
Isfehan
Postal code
8174173461
Phone
+98 31 3668 5555
Email
hamidshetabi@med.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
Al-Zahra Medical Center, Department of Anesthesia, Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 3668 4510
Email
hamidshetabi@med.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 and health researchers
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@med.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