Protocol summary

Summary
The aim of this study is to evaluate the effect of N2O on the required dose of propofol in creating the perfect sedation for painful procedures in children. The first, 88 children who are candidates for bone marrow aspiration, are randomly divided into 2 groups. In Group I, combination of midazolam 0/03 mg / kg and fentanyl 1 μg / kg and ketamine 1 mg / kg and propofol 1 mg / kg are injecting intravenously. In Group II ,combination of midazolam 0/03 mg / kg and fentanyl 1 μg / kg and ketamine 1 mg / kg and propofol 1 mg / kg are injecting intravenously and from 2 minutes before the start of the procedure until the end of the procedure the patient is used to ventilate the gas entonox. In both groups, the aim is achieve to sedation Level 4 is based on Ramsay sedation scale, if necessary, every 1 minute ,propofol 1 mg / kg to be administered intravenously. The SpO2 and HR record before drug administration, immediately before the start of the procedure, at the beginning of the procedure, at the end of the procedure. The satisfaction will be evaluated and documented, by the physician performing the procedure and help nurse him by VAS (0-10). In addition to ,age, weight, duration of procedure, recovery time, the prescription drugs for each patient and the occurrence of any complication record.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090513364N2
Registration date: 2016-12-05, 1395/09/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-05, 1395/09/15
Registrant information
Name
Mehrdad Taheri
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 7840
Email address
m.taheri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology,Shahid Beheshti University Of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-11-01, 1394/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nitrous Oxide for propofol requirement in painful procedures in pediatric oncology unit
Public title
Doing sedation in paediatric
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:patients undergoing bone marrow biopsy (the first turn) exclusion criteria:History of asthma;Catching common cold;detection of any complications during the procedure ( apnea;%90 ≥ SPo2;Bradycardia > %30 of baseline);Doing any previous procedure with sedation;Parent discontent;Not fasting;History of hypersensitivity to any of the drugs
Age
From 1 day old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
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
Vice Chancellor for Research and Technology,Shahid Beheshti University Of Medical Sciences
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
tehran
Postal code
198396-3113
Approval date
2014-10-26, 1393/08/04
Ethics committee reference number
sbmu.rec.1393.363

Health conditions studied

1

Description of health condition studied
AML
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukaemia [AML]

2

Description of health condition studied
ALL
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukaemia [ALL]

Primary outcomes

1

Description
sedation scale
Timepoint
1 minute
Method of measurement
Ramsay sedation scale

Secondary outcomes

1

Description
Recovery time
Timepoint
After the procedure
Method of measurement
minute

2

Description
SpO2
Timepoint
Before administration of drugs - immediately before the procedure - at the beginning of the procedure - at the end of the procedure
Method of measurement
Pulse Oximeter

3

Description
heart rate
Timepoint
Before administration of drugs - immediately before the procedure - at the beginning of the procedure - at the end of the procedure
Method of measurement
Pulse Oximeter

4

Description
Physician satisfaction
Timepoint
During the procedure
Method of measurement
VAS (10-0)

5

Description
Nurse satisfaction
Timepoint
During the procedure
Method of measurement
VAS (10-0)

Intervention groups

1

Description
In the control group, combination of midazolam 0/03 mg / kg and fentanyl 1 μg / kg and ketamine 1 mg / kg and propofol 1 mg / kg are injecting intravenously.
Category
Treatment - Drugs

2

Description
In the study group, combination of midazolam 0/03 mg / kg and fentanyl 1 μg / kg and ketamine 1 mg / kg and propofol 1 mg / kg are injecting intravenously and the patients are ventilated with entonox, 2 minutes before the start of the procedure until the end of the procedure.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Mehrdad Taheri
Street address
Madani Ave
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology,Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Mostafa Alavimoghaddam
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology,Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
assistant professor of anesthesiology
Other areas of specialty/work
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
tehran
Postal code
Phone
+98 21 23871
Fax
Email
taheri.1352@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
assistant professor of anesthesiology
Other areas of specialty/work
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
tehran
Postal code
Phone
+98 21 23871
Fax
Email
taheri.1352@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
assistant professor of anesthesiology
Other areas of specialty/work
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 7756 7840
Fax
Email
taheri.1352@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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