Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening
- Conditions
- Pain
- Registration Number
- NCT00482560
- Lead Sponsor
- University of Turin, Italy
- Brief Summary
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
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Term neonates, gestational age 37-42 weeks
- Apgar >= 7
- Not fed in the last 30 minutes
- Informant consent
- Congenital malformation
- Born in Caesarian Section in General Anaesthesia
- Maternal use of opioids
- Administration of Naloxone, Phenobarbital in the previous 48 hours
- Impossibility of breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Premature Infant Pain Profile (PIPP) scale rate (0-21) 15 seconds before and Within 30 seconds after heel lance
- Secondary Outcome Measures
Name Time Method Heart Rate Increase within 30 seconds after heel lance Oxygen Saturation decrease within 30 seconds after heel lance Duration of first cry within 2 minutes after heel lance Percentage of crying time During blood sampling
Trial Locations
- Locations (1)
Agnelli Hospital ASL 10
🇮🇹Pinerolo, Torino, Italy