Comparison of the Efficacy of Oral Sucrose Administration at Two Different Times of a Painful Procedure in Neonates.
Comparison of the Effectiveness of Administering 24% Oral Sucrose Two Minutes Before Versus at the Same Time in the Performance of a Painful Procedure in the Neonate.
1 other identifier
interventional
74
1 country
1
Brief Summary
The objective of this study is to compare the use of 24% sucrose in pain control in neonates from 32 weeks of gestation onwards according to the time of administration of sucrose in venous and arterial puncture for blood collection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2022
CompletedFirst Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2022
CompletedJanuary 20, 2023
January 1, 2023
6 months
April 5, 2022
January 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Pain during a painful procedure
The primary variable is pain, and will be measured by the Premature Infant Pain Profile-Revised (PIPP-R) scale. The score ranges from 0 (no pain or minimal pain) to 21 (maximum pain).
15 seconds after extraction
Study Arms (2)
Control Group
ACTIVE COMPARATORSucrose will be administered 2 minutes before the puncture following the current protocol of the unit. Venous or arterial puncture will be performed only in case it is required for therapeutic or care purposes.
Experimental Group
EXPERIMENTALThe administration of the sucrose dose is started by means of a syringe. Once 50% of the dose has been administered, puncture will be performed. The remaining 50% will be administered during the puncture. The pacifier will be left in the mouth until the end of the procedure, facilitating the non-nutritive sucking of the neonate.
Interventions
According to the age of the newborn: 24-26 weeks : 0.1 mL, 27-31weeks : 0.25 mL, 32-36 weeks : 0.5 mL, \>37 weeks : 1 mL
Eligibility Criteria
You may qualify if:
- Neonates whose parents and/or guardians have signed the informed consent form.
You may not qualify if:
- Neonates connected to invasive mechanical ventilation.
- Neonates presenting any type of neurological alteration or showing signs of irritability prior to the puncture.
- Neonates who have received sedation.
- Neonates presenting withdrawal syndrome.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Araba-Sede Txagorritxu
Vitoria-Gasteiz, Alava, 01009, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Neonatal unit nurse
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 12, 2022
Study Start
September 1, 2021
Primary Completion
February 14, 2022
Study Completion
October 11, 2022
Last Updated
January 20, 2023
Record last verified: 2023-01