Comparisonal Survey the Effect of Sucrose oral Solution (20%) with Sterile Water on Severity of Pain During Venipuncture in Premature Neonates Who were Admitted to Motahhari Educational Center of Urmia in 2019 to 2020
Determine of the Effect of Sucrose oral Solution (20%) with Sterile Water on Severity of Pain During Venipuncture in Premature Neonates Who were Admitted to Motahhari Educational Center of Urmia in 2019 to 2020
Design
A randomized controlled clinical trial with parallel, double-blind, randomized by the random number table method
Settings and conduct
In the Maternity ward of Shahid Motahari Hospital of Urmia, 150 infants will be randomly assigned to three groups a, b and c. Two minutes before the aqueous injection of group a 20% sucrose oral solution, group b will receive distilled water and group c will receive no intervention. Neonatal behavioral response will be assessed before, 2 minutes and 7 minutes after venipuncture.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Ages 2 to 5 days after birth
First minute Apgar score of 7-10
No painful interventions such as resuscitation and blood sampling etc.
Exclusion criteria:
Maternal opioid use
Infant's heart, respiratory and developmental problems
Intervention groups
Infants receiving sucrose solution 20%
Infants receiving sterile water
Main outcome variables
Neonatal behavioral response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200225046615N1
Registration date:2020-04-07, 1399/01/19
Registration timing:prospective
Last update:2020-04-07, 1399/01/19
Update count:0
Registration date
2020-04-07, 1399/01/19
Registrant information
Name
Hosein Habibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4961
Email address
habibzadeh.h@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisonal Survey the Effect of Sucrose oral Solution (20%) with Sterile Water on Severity of Pain During Venipuncture in Premature Neonates Who were Admitted to Motahhari Educational Center of Urmia in 2019 to 2020
Public title
The Effect of Sucrose oral Solution (20%) with Sterile Water on Severity of Pain During Venipuncture in Premature Neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Births at 2 to 4 weeks of gestation
Weights of 1.5 kg and more
Ages 2 to 5 days after birth
First minute Apgar score of 7-10
No painful interventions such as resuscitation and blood sampling etc
Exclusion criteria:
Breastfeeding 5 minutes before venipuncture
Take acetaminophen on the same day and Naloxone or Phenobarbital in the last 7 hours
Maternal opioid use
Infant's heart, respiratory and developmental problems
Age
From 1 day old to 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method was block randomization and from among 200 eligible preterm infants that met the inclusion criteria, 150 infants were selected randomly using www.randomizer.org.
Then, three control groups, Sucrose, 20% and oral Solution were considered, so that we randomly placed the tip of the pen on the Random letter table. If the letter c came, the baby in the control group. And if the letter A came, the premature baby would be in the distilled water group, and this would continue until 50 infants were completed for each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each of the Sucrose oral Solution (20%) and Sterile Water,will be placed in the same container with codes 1 and 2 and the researcher and statistical analyst will have no knowledge of the type of solution, and only the nurse who will administer the solution to infants. The researcher will be aware of the solutions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Approval date
2019-12-18, 1398/09/27
Ethics committee reference number
IR.UMSU.REC.1398.347
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Neonatal behavioral response
Timepoint
2 and 7 minutes after oral administration
Method of measurement
Neonatal Infant Pain Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Two minutes before venipuncture, give 20 ml of infant 20% sucrose solution
Category
Treatment - Drugs
2
Description
Intervention group: Two minutes before the infant is fed a half-ml solution of distilled water to infants