We will compare the analgesic effect of sucrose 20%, 30% and 50% in 120 healthy term newborns that receive intramuscular vitamin k. The babies will randomly be divided into the 4 groups. Each group will receive 1ml of oral sucrose 20%, 30% or 50% or sterile water. Response to pain will assess by Neonatal Infant Pain Scale (NIPS) immediately after injection and 5 minutes after.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902223920N1
Registration date:2010-06-16, 1389/03/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-06-16, 1389/03/26
Registrant information
Name
Fatemeh Morady
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 6529
Email address
morady-f@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2010-08-24, 1389/06/02
Expected recruitment end date
2011-08-24, 1390/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison The effect of oral sucrose 20%, 30% and 50% on relief of behavioural pain responses caused by vitamin k injection in full term infants
Public title
The effectiveness of sucrose in neonatal pain relief
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age 37-42 weeks, weight above 2/5 kg, age 1-2 day, Apgar (first min) >= 7. Exclusion criteria: crying, illness, using Naloxan
Age
From 1 year old to 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Semnan University of Medical Sciences
Street address
Amir Kabir Av.
City
Semnan
Postal code
Approval date
2010-05-15, 1389/02/25
Ethics committee reference number
2337/2/21
Health conditions studied
1
Description of health condition studied
Pain caused by vitamin k IM injection
ICD-10 code
Z76.2
ICD-10 code description
Health supervision and care of other healthy infant and child
Primary outcomes
1
Description
Pain
Timepoint
Immediately after injection and 5 minutes later
Method of measurement
Neonatal Infant Pain Scale (NIPS)
Secondary outcomes
empty
Intervention groups
1
Description
Sucrose 20%, 1cc oral
Category
Other
2
Description
Sucrose 30%, 1cc oral
Category
Other
3
Description
Sucrose 50%, 1cc oral
Category
Other
4
Description
Sterile Water, 1cc oral
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Street address
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Ghorbani
Street address
Semnan, Amir Kabir Av.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Morady
Position
Master Science of Nursing
Other areas of specialty/work
Street address
Semnan, Dehkhoda Av., Miaade 5 St.
City
Semnan
Postal code
Phone
+98 23 1444 6529
Fax
Email
fatemeh_mrdy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Morady
Position
Master Sciences of Nursing
Other areas of specialty/work
Street address
Semnan, Dehkhoda Av., Miaade 5 St.
City
Semnan
Postal code
Phone
+98 23 1444 6529
Fax
Email
fatemeh_mrdy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Fatemeh Morady
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)