Comparison of the effect of sucrose and glucose on neonatal pain during invasive procedures in the neonatal intensive care unit of Kashan Beheshti Hospital
Comparative study of the effect of sucrose and glucose on neonatal pain during invasive procedures in the neonatal intensive care unit of Kashan Beheshti Hospital
Design
Clinical trial with two parallel intervention groups, double blind, non- randomized, phase 2, on two groups of 30 people (total of 60 patients)
Settings and conduct
Neonatal intensive care unit of Kashan Beheshti Hospital. Two minutes before performing 3 invasive procedures, 0.1 to 2 cc of sucrose solution in group 1 and the same amount of glucose solution in group 2 will be used. The solutions will be sprayed on the anterior surface of the tongue.
Participants/Inclusion and exclusion criteria
Inclusion criteria: admitted infants into the intensive care unit; birth in weeks 27 to 40 weeks of gestation, presence of sucking reflex and swallowing. Exclusion criteria: feeding the baby 30 minutes before injection, receiving acetaminophen on the same day, heart, neurological and developmental problems، no of GAG reflex, maternal opioid use, naloxone or phenobarbital use in the last 48 hours.
Intervention groups
In the first group of the intervention, the amount of 0.1 to 2 cc of 24% sucrose solution and In the second intervention group, the same amount of 20% glucose will be used 2 minutes before performing 3 invasive procedures.The Neonatal Pain Scale will be used to assess pain.
Main outcome variables
Neonatal pain during invasive procedures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201004048918N1
Registration date:2020-11-02, 1399/08/12
Registration timing:retrospective
Last update:2020-11-02, 1399/08/12
Update count:0
Registration date
2020-11-02, 1399/08/12
Registrant information
Name
Mahin Safayee moghane
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5543 4038
Email address
mahin.safayee@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of sucrose and glucose on neonatal pain during invasive procedures in the neonatal intensive care unit of Kashan Beheshti Hospital
Public title
Comparison of the effect of sucrose and glucose on neonatal pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization of infants in the neonatal intensive care unit
Gestational age of 27 to 40 weeks
Existence of swallowing and sucking reflex
Exclusion criteria:
Feed the baby 30 minutes before the injection
Take acetaminophen on the same day
Opioid use by the mother
Existence of cardiorespiratory, developmental and neurological problems
Lack of gag reflex
Receive naloxone or phenobarbital in the last 48 hours
Age
To 28 days old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind.Sucrose is indicated by code A and glucose by code B.Participants in this study and nurses who assist in gathering information are unaware of the type of solutions. Only the researcher knows the type of solutions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University-Isfahan Branch (Khorasgan)
Street address
East Jay St. - Purple - University Blvd.
City
Esfahan
Province
Isfehan
Postal code
۸۱۵۵۱-۳۹۹۹۸
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.IAU.KHUISF.REC.1399.173
Health conditions studied
1
Description of health condition studied
Infants admitted to the hospital with respiratory problems, premature infants, low birth weight
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduce pain in infants
Timepoint
Measurement of pain when performing 3 invasive procedures on infants.Includes venous venipuncture, arterial blood draw, lumbar puncture
Method of measurement
Use of infant pain measurement tools-pipp
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:The group receiving sterile sucrose 24% , which will be prepared as a package of 5 ml polyethylene ampoule from Shahid Ghazi Pharmaceutical Company located in Tabriz.And will be used orally with a syringe and without a needle head.2 minutes before the invasive procedure,An amount of 0.1 to 2 cc of 24% sucrose solution is injected on the anterior surface of the baby's tongue.The procedure is then performed and the pain score is measured.The maximum effect of sucrose is up to 5 minutes.If the procedure is prolonged, the dose can be repeated.
Category
Prevention
2
Description
Intervention group 2:The group receiving glucose.20% liquid glucose will be provided by Shahid Ghazi Pharmaceutical Company located in Tabriz and will be used orally using a needleless syringe.2 minutes before the invasive procedure,0.1 to 2 cc of glucose 20 solution is injected on the anterior surface of the baby's tongue.The procedure is then performed and the pain score is measured.The baby will be monitored for 30 seconds.The maximum effect of glucose is up to 5 minutes.If the procedure is prolonged, the dose can be repeated.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Mohammad Reza Sharif
Street address
Qutb Ravandi Blvd., Pezeshk Blvd.
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoumeh Tabatabai
Street address
Safaieh, Boulevard of the Unknown Martyrs
City
YAZD
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Fax
+98 35 3821 4810
Email
riasat@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maasoumeh Barkhordari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Safaieh, Boulevard of the Unknown Martyrs
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 1391
Email
Barkhordari-m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maasoumeh Barkhordari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Safaieh, Boulevard of the Unknown Martyrs
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3821 0540
Email
Barkhordari-m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Safaei Mahin
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Police Square, Bustan Boulevard, 4 Shabnam
City
Kashan
Province
Isfehan
Postal code
8741713484
Phone
+98 31 5543 4038
Email
mahin.safayee@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Patient information is confidential and non-disclosable. No further information available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available