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Non-pharmacological Analgesia During Heel Prick

NCT01576432 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2012-04-12

No results posted yet for this study

Summary

Objective

To investigate the analgesic effect (measured with NIPS) of breastfeeding in addition to skin-to-skin contact versus other methods of non-pharmacological analgesia during blood sampling through heel lance in healthy term neonates. The influences of non-pharmacological methods on crying time, percentage of crying while sampling, heart rate, number of attempts and duration of sampling were studied.

Methods

Randomised controlled trial performed on 136 healthy term newborns in the maternity ward of a tertiary hospital. The inclusion criteria were: healthy term neonates, wish to breastfeed and absence of feeding during the previous 60 minutes. Neonates were randomly assigned to four groups: group 1, breastfed with skin-to-skin contact ; group 2, oral sucrose with skin-to-skin contact ; group 3, skin-to-skin contact ; or group 4, receiving oral sucrose Data for the primary objective was analysed per intention to treat. This study was approved by local ethical committee.

Conditions

  • Pain
  • Breastfeeding

Interventions

BEHAVIORAL

Assess pain with the NIPS score

In group 1 (BF+SSC), neonates dressed with a diaper were held in prone, in SSC with the mother; BF was started at least 5 minutes before heel lance and maintained during sampling. In group 2 (sucrose + SSC), neonates were held in prone between the mothers' breast at least 5 minutes before sampling and 2 ml 24% sucrose was given with a sterile syringe in the mouth 2 minutes before heel lance. In group 3 (SSC), neonates were held between the mother's breast as in group 2, but no sucrose was given. In group 4 (Sucrose), 2 ml 24% sucrose was administered through a sterile syringe in the mouth 2 minutes before heel lance to neonates laid on supine on a cot; the procedure was done in the presence of the mother. Mothers were allowed to speak or touch their babies in all the groups.

Sponsors & Collaborators

  • Puerta de Hierro University Hospital

    lead OTHER

Principal Investigators

  • Miguel A Marín Gabriel, MD · Deparment of Pediatrics. Hospital Universitario Puerta de Hierro-Majadahonda. Madrid. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
37 Weeks
Max Age
41 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-02-29
Completion
2012-04-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576432 on ClinicalTrials.gov