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Analgesic Efficacy of Different Doses of Sucrose During Blood Sampling in Preterm Infants

NCT02859376 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2016-08-09

No results posted yet for this study

Summary

The objective of this trial is to compare the analgesic effect of a single dose of oral sucrose 24% administered two minutes before a blood sampling (either heel prick or vascular puncture) versus multiple doses of oral sucrose 24% administered two minutes before and during the procedure in a population of preterm newborns of Gestational Age ≤ 36+6 weeks hospitalized in Neonatal Intensive Care Unit, using neonatal pain scales (Premature Infant Pain Profile (PIPP), Face, Legs, Activity, Cry, Consolability (FLACC) and indirect Visual Analogue Scale (VAS)) and Skin Conductance (SC) measurement (Pain Monitor).

Conditions

Interventions

DIETARY_SUPPLEMENT

sucrose 24%

Premature neonates undergoing blood samples through skin breaking procedures, meeting inclusion criteria, will be randomized as soon as the doctor decision to drown the blood is made, to either sucrose 24% 0,3 mL if \< 1000 g or 0,5 mL if \> 1000 g two minutes BEFORE the skin breaking procedure or sucrose 24% 0,3 mL if \< 1000 g or 0,5 mL if \> 1000 g two minutes BEFORE and DURING the skin breaking procedure, according to a computer generated randomization list.

Sponsors & Collaborators

  • University Hospital Padova

    lead OTHER

Principal Investigators

  • Paola Lago, MD

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02859376 on ClinicalTrials.gov