Pain intensity analysis in different groups who receiving Glucose, Sacarose and control following vaccination against hepatitis B in newborns of Shahid Mostafa Khomaini hospital of Ilam
This is double-blinded clinical trial that will be performing in shahid Mustafa Khomeini hospital of ilam city. The aim of study is examination the effect of Glucose and sacarose on pain due to newborns vaccination in 90 newborn. Inclusion criteria: 1-dryness of newborn diapers. 2-no disease or surgical procedures.
3-full term newborn. 4-no analgesics usage for newborn.
5-NPO at least 30 min before injection of vaccine. Exclusion criteria: 1- presence of abnormality.
2- pre-term newborns. The samples will be select by convenience method and assigned in groups of sacarose, Glucose and control randomly. In first mentioned groups researcher give 2cc oral Glucose 25% and sacarose25% through syringe in 30 s then after 2 min, Hepatitis-B vaccine injected and the pain severity measured by NIPS scale during 1-2 min. In control group there is no intervention.Hepatitis-B vaccine injected and the pain severity measured by NIPS scale during 1-2 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304096790N3
Registration date:2013-05-22, 1392/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-22, 1392/03/01
Registrant information
Name
Zainab Suhrabi
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 1222 7123
Email address
suhrabi-z@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology, Ilam University of Medical Sciences
Expected recruitment start date
2013-05-05, 1392/02/15
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pain intensity analysis in different groups who receiving Glucose, Sacarose and control following vaccination against hepatitis B in newborns of Shahid Mostafa Khomaini hospital of Ilam
Public title
Pain intensity analysis in different groups who receiving Glucose, Sacarose and control following vaccination against hepatitis B in newborns of Shahid Mostafa Khomaini hospital of Ilam
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1-dryness of newborn diapers.
2-no disease or surgical procedures.
3-full term newborn.
4-no analgesics usage for newborn.
5-NPO at least 30 min before injection of vaccine.
Exclusion criteria:
1- presence of abnormality.
2- pre-term newborns.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ilam University of Medical Sciences
Street address
Banganjab- Pajohesh Blvd.
City
Ilam
Postal code
Approval date
2012-01-18, 1390/10/28
Ethics committee reference number
999/52/22
Health conditions studied
1
Description of health condition studied
Vaccination pain
ICD-10 code
Z51.4
ICD-10 code description
Preparatory care for subsequent treatment, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
During vaccine injection
Method of measurement
NIPS criteria
Secondary outcomes
empty
Intervention groups
1
Description
In sacarose group researcher give 2cc oral sacarose25% through syringe in 30 s then after 2 min, Hepatitis-B vaccine injected and the pain severity measured by NIPS scale during 1-2 min
Category
Prevention
2
Description
In Glucose group researcher give 2cc oral Glucose 25% through syringe in 30 s then after 2 min, Hepatitis-B vaccine injected and the pain severity measured by NIPS scale during 1-2 min
Category
Prevention
3
Description
In control group there is no intervention.Hepatitis-B vaccine injected and the pain severity measured by NIPS scale during 1-2 min
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mustafa Khomeini hospital
Full name of responsible person
Zainab Suhrabi
Street address
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Morovat Taheri kalani
Street address
Banganjab-Deputy of research and technology
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Zainab suhrabi
Position
Faculty member- lecturer
Other areas of specialty/work
Street address
Banganjab- Pajoheh Blvd
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
suhrabi2007@yahoo.comsuhrabi-z@medilam.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Zainab suhrabi
Position
MS
Other areas of specialty/work
Street address
Banganjab- pajohesh Blvd
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
suhrabi2007@yahoo.comsuhrabi-z@medilam.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University Of Medical Sciences
Full name of responsible person
Zainab Suhrabi
Position
Faculty member- lecturer
Other areas of specialty/work
Street address
Banganjab- Pajohesh Blvd.
City
Ilam
Postal code
Phone
+98 84 1222 7123
Fax
Email
suhrabi2007@yahoo.comsuhrabi-z@medilam.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)