Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

University of Turin

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Behavioral: Breastfeeding; Drug: Sucrose solution 30%1 ml

Study type: Interventional

Funder types: Other

Identifiers

NCT00482560

PRN19341

Details and patient eligibility

About

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

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 2 to 5 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Term neonates, gestational age 37-42 weeks
• Apgar >= 7
• Not fed in the last 30 minutes
• Informant consent

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)