Primary Outcome Measures:
- Premature Infant Pain Profile (PIPP) scale rate (0-21) [ Time Frame: 15 seconds before and Within 30 seconds after heel lance ]
Secondary Outcome Measures:
- Heart Rate Increase [ Time Frame: within 30 seconds after heel lance ]
- Oxygen Saturation decrease [ Time Frame: within 30 seconds after heel lance ]
- Duration of first cry [ Time Frame: within 2 minutes after heel lance ]
- Percentage of crying time [ Time Frame: within 2 minutes after heel lance ]
- Percentage of crying time [ Time Frame: During blood sampling ]
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
- The heel of neonate was warmed up by a glove full of water at 40° C for 2 minutes.
- Monitoring of Oxygen Saturation and Heart Rate.
- The neonate was breastfed by the mother till the nurse watched a continuous active suction.
- Administration of first phase of PIPP scale (15 seconds before heel lance).
- Digital Voice Record started
- Heel Lance with an automated piercing device .
- Squeezing for blood sampling till filling 4 catch basins for neonatal screening. If necessary a new heel lance was practiced.
- Administration of the second phase of PIPP scale.
- Record of duration of blood sampling and collateral effects
- Stop Digital Voice Recording
Group B Sucrose administration
- The neonate was laid on a baby-changing table.
- The heel of neonate was warmed up by a gloves full of water a 40° C for 2 minutes.
- Oral administration of 1 ml of 30% sucrose solution.
- Monitoring of Oxygen Saturation and Heart Rate.
- Administration of first phase of PIPP scale (15 seconds before heel lance).
- Digital Voice Record starts
- Heel Lance with an automated piercing device.
- Squeezing for blood sampling till filling 4 catch basins for neonatal screening. If necessary a new heel lance was practiced.
- Administration of the second phase of PIPP scale.Record of duration of blood sampling and collateral effects.
- Stop Digital Voice Recording
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).
Purpose
