Aim: Compare the effect of pacifier with sucrose (non-medical method) in pain management in the neonatal intensive care unit. In this non-randomized clinical trial, 40 infants were selected.
Inclusion criteria: Term infants (Gestational age 38 to 42 weeks); normal birth weight (2500 to 4000 grams), fifth minute APGAR score≥ 7.
Exclusion criteria: Congenital defects; Infection and wound at the site of venipuncture; Serious disease symptoms such as septicemia after 24 hours from the test; unsuccessful try in venipuncture. In the first intervention, nothing will be done before the venipuncture for pain control. Newborn pain will be measured before and at the venipuncture time and after three minutes of venipuncture. Next time، 2 minutes before venipuncture a proportional pacifier will be put in baby’s mouth. Pain in newborns will be measured after 2 minutes, at the time of venipuncture and after three minutes of venipuncture (actually three times).
Next time, 2 cc of 24% sucrose solution will be given to the same baby. The pain will be measured three times (eg. after 2 minutes, at the time of venipuncture and after three minutes of venipuncture)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092329921N1
Registration date:2017-07-01, 1396/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-01, 1396/04/10
Registrant information
Name
Firoozeh Darvishi
Name of organization / entity
Shahid Bbeheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7704 5639
Email address
fi.darvishi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Researcher
Expected recruitment start date
2016-06-30, 1395/04/10
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of pacifier and sucrose (non-medical method ) in pain management In the neonatal intensive care unit
Public title
Comparison the effect of pacifier and sucrose (non-medical method) in pain management.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Term infants (Gestational age 38 to 42 weeks); normal birth weight (2500 to 4000 grams), fifth minute APGAR score≥ 7.
Exclusion criteria: Congenital defects; Infection and wound at the site of venipuncture; Serious disease symptoms such as septicemia after 24 hours from the test; unsuccessful try in venipuncture.
Age
From 1 day old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences And Health Services.
Street address
Velenjak، 7th Floor، Bldg No، 2 SBUM، SArabi Ave.
City
Tehran
Postal code
1983969411
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.SBMU.RETECH.REC.1395.226
Health conditions studied
1
Description of health condition studied
does not have
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
PAIN
Timepoint
before intervention، during intervention، before intervention
Method of measurement
NIPS
Secondary outcomes
empty
Intervention groups
1
Description
Use of routine care, 2 minutes before intervention.
Category
Prevention
2
Description
Use of 2 ml of sucarose24%، 2 minutes before intervention.
Category
Treatment - Drugs
3
Description
used of pacifier2 minutes before intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid hospital
Full name of responsible person
Maryam Momeny
Street address
Mofid Hospital, Shariati street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mofid Hospital
Full name of responsible person
Mohamad Kazemiyan
Street address
Mofid Hospital, Shariati street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mofid Hospital
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
Mofid Hospital
Full name of responsible person
Nazanin Keshavarz
Position
MS in student
Other areas of specialty/work
Street address
Mofid Hospital، Shariati Street، Tehran
City
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Fax
+98 21 2222 0254
Email
nazanin8059@yahoo.com
Web page address
www.mch.sbmu.ac.
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Alaee
Position
Phd of nursing
Other areas of specialty/work
Street address
Daneshjo Blvd., Shahriari Sq., Yemen St., Chamran Highway, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
falaeekarahroudy@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mofid Hospital
Full name of responsible person
Fateme ghafari
Position
Nurse
Other areas of specialty/work
Street address
Shariati street، mofid hospital، Tehran
City
Tehran
Postal code
Phone
+98 21 2222 7021
Fax
Email
t.momeni@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)