Comparative evaluation of the effect of propofol_ketamine and propofol_remifentanil for deep sedation and analgesia during painful procedures in 6 month to 14 year old children with acute lymphoblastic leukemia
Abstract
Objective: Comparing the effectiveness of two drug combinations of Propofol-Ketamine and Propofol-Remifentanil in children with acute lymphoblastic leukemia under bone marrow aspiration or biopsy and lumbar puncture.
Methods: In a clinical trial, 81 children of 6 months to 14 years old with acute lymphoblastic leukemia who were candidates for lumbar puncture, bone marrow aspiration or biopsy were randomly divided into two groups of receiving Propofol-Ketamine and receiving Propofol-Remifentanil. In each group, hemodynamic indices, sedation, side effects, the onset of effectiveness and duration of remaining in the recovery room were measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080935601N1
Registration date:2017-11-19, 1396/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
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
Deputy of Research of Isfahan University of Medical Sciences
Expected recruitment start date
2016-09-19, 1395/06/29
Expected recruitment end date
2017-02-13, 1395/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effect of propofol_ketamine and propofol_remifentanil for deep sedation and analgesia during painful procedures in 6 month to 14 year old children with acute lymphoblastic leukemia
Public title
The effect of propofol_ketamine and propofol_remifentanil for deep sedation and analgesia during painful procedures in 6 month to 14 year old children with acute lymphoblastic leukemia in sayedoshohada Medical Center in Isfahan in 2016.
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were included, Children aged between Six months to fourteen years old with Hematologic Malignancies (such as acute lymphocytic leukemia) were candidates for painful intervention Lumbar Puncture; Bone marrow aspiration/Biopsy. Non-entry criteria include patients with head trauma; High intraocular pressure (IOP); or High intracranial pressure (ICP); cardiovascular or repertory or liver diseases; epilepsy or history of seizure; Neurological disorder ;tumor or metastasis of the brain; usage of analgesic or sedative drugs in before intervention; chronic pain syndrome; and not having to participate in the study; history of allergy or allergic reaction to Our study drugs Excluded criteria include any complications during intervention that causes the anesthetic program to change
Age
From 6 months old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
81
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
isfahan
Postal code
Approval date
2016-09-19, 1395/06/29
Ethics committee reference number
IR.mui.rec.1395.3.462
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukaemia [ALL]
ICD-10 code
C91.0
ICD-10 code description
This code should only be used for T-cell and B-cell precursor leukeamia
Primary outcomes
1
Description
Sedation Level
Timepoint
During Procedure
Method of measurement
University of Michigan Sedation Scale (UMSS)
2
Description
Analgesia
Timepoint
During Procidure
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 Every 5 minutes during the procedure and Every 10 minutes in recovery
Method of measurement
Cardiac monitoring and automatic blood pressure monitoring
2
Description
Arterial oxygen saturation
Timepoint
Before and every 5 minutes during the procedure and Every 10 minutes in recovery
Method of measurement
Pulse oximeter
Intervention groups
1
Description
Group 1 Propofol Ketamine (PK) Syringes No. 1, 2 and 3 containing propofol at a concentration of 1 mg per cc, ketamine with a concentration of 0.3 mg per cc, and normal saline (as placebo)
1 cc per kilogram of weight from syringes 1 and 2 at the start of sedation and before prep and drep Syringe number 3 was injected.
Category
Treatment - Drugs
2
Description
Group II propofol remifentanil (PR) syringe number 4, containing propofol at a concentration of 1.5 mg / kg,
syringe number 5 containing remifentanil at a concentration of 1mcg / kg and syringe number 6 normal saline (as a placebo) of 1 cc/kg ,
Syringes 4 and 5 were injected at the start of sedation and before the prep and drep, the syringe 6 was injected
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed Shahada Hospital in Isfahan
Full name of responsible person
Hamidreza Shetabi
Street address
Khayyam Street, Kay Nahr Farshad Hospital, Seyed Alshohada Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nejatbakhsh DR
Street address
Hezar jerib , Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Other areas of specialty/work
Street address
Sofe Bolvar , Al-Zahra Medical Center, Department of Anesthesia
City
Iisfahan
Postal code
8174675731
Phone
+98 31 3668 5555
Fax
+98 31 3668 4510
Email
hamidshetabi@mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Science
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Other areas of specialty/work
Street address
Sofe bulvar, Alzahra Medical Center, Department of Anesthesia
City
Iisfahan
Postal code
Phone
+98 66 85555
Fax
Email
hamidshetabi@mui,ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Other areas of specialty/work
Street address
Sofe bulvar , Alzahra Medical Centerl, Department of Anesthesia
City
Iisfahan
Postal code
Phone
+98 316685555
Fax
Email
hamidshetabi@mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)