Agnelli Hospital ASL 10
Pinerolo, Torino, 10064, Italy
NCT Number: NCT00482560
The purpose of this study is to compare the antinociceptive effect of 1 ml of 30% sucrose solution vs breastfeeding on neonatal screening heel lance
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All sexes
Interventional
Phase 3
Pinerolo, Torino, 10064, Italy
Blood sampling heel lance for neonatal screening is the most frequent painful manoeuvre in Neonatal Units in healthy neonates.
Some techniques showed efficacy evidence in reducing pain response: sucrose solutions, breastfeeding during blood sampling, topical local anaesthetics.
A Cochrane Review in 2004 recommends the administration of sucrose 0.24-0.48 g (1-2 ml of 24% sucrose solution). It reduces PIPP scale rate about 20%.
Our purpose is to compare the antinociceptive effect of 1 ml 30% sucrose solution administered 2 minutes before heel lancing vs blood sampling heel lance during breastfeeding.
PIPP scale is a validated 7-indicator scale for the assessment of procedural pain in preterm and term neonates.
Informant consent was asked parents during consultation by a Pediatrician of the Neonatal Unit of the Hospital in the last months of pregnancy.
After parent written consent was obtained, 100 three day old neonates were randomized for treatment A (breastfeeding) or B (sucrose solution administration). The nurse opened consecutively numbered envelopes.
Timing of operators: Group A Breastfeeding
Group B Sucrose administration
Blood sampling was practiced by skilled pediatric nurses. Registration of data, PIPP scale, voice record was made by a second operator, blind to the pur pose of the study.
A third blind operator collected paper data and checked voice record (outcome cry behaviour).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 15 seconds before and Within 30 seconds after heel lance
Time frame: within 30 seconds after heel lance
Time frame: within 30 seconds after heel lance
Time frame: within 2 minutes after heel lance
Time frame: within 2 minutes after heel lance
Time frame: During blood sampling
University of Turin, Italy
Other
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