Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

Pain Clinical Trial

Official title:

Analgesic Effect of Breast Feeding vs Sucrose in Neonatal Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482560
• Other study ID #: PRN19341
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2007
• Last updated: June 28, 2007
• Start date: January 2007
• Est. completion date: April 2007

Study information

• Verified date: June 2007
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Sucrose solution 30%1 ml

Behavioral:
• Breastfeeding

Locations

Country	Name	City	State
Italy	Agnelli Hospital ASL 10	Pinerolo	Torino

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Agnelli Hospital, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Ballantyne M, Stevens B, McAllister M, Dionne K, Jack A. Validation of the premature infant pain profile in the clinical setting. Clin J Pain. 1999 Dec;15(4):297-303. — View Citation

Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. — View Citation

Shah PS, Aliwalas LI, Shah V. Breastfeeding or breast milk for procedural pain in neonates. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004950. Review. Update in: Cochrane Database Syst Rev. 2012;12:CD004950. — View Citation

Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2004;(3):CD001069. Review. Update in: Cochrane Database Syst Rev. 2010;(1):CD001069. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature Infant Pain Profile (PIPP) scale rate (0-21)		15 seconds before and Within 30 seconds after heel lance
Secondary	Heart Rate Increase		within 30 seconds after heel lance
Secondary	Oxygen Saturation decrease		within 30 seconds after heel lance
Secondary	Duration of first cry		within 2 minutes after heel lance
Secondary	Percentage of crying time		within 2 minutes after heel lance
Secondary	Percentage of crying time		During blood sampling