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Pain Reactivity to Non-Pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit

NCT00758511 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2013-11-15

No results posted yet for this study

Summary

Switzerland is having one of the highest premature rates in Europa and most of the preterm neonates need neonatal intensive care. Up to 80% of the analgesic used in neonatal intensive care units are either "off label used" or "non-licensed" used. As an alternative approach non-pharmacological interventions for pain prevention and relief are increasingly being recommended for the prevention and treatment of mild and moderate pain in this population.

This multicenter pilot study will use a randomized three group,repeated measures design.

The primary aims of this study of premature neonates are to:

1.) Estimate effect sizes for the impact of the proposed interventions(facilitated tucking alone, sucrose alone and sucrose in combination with tucking)on pain reactivity.

2.) Examine the impact of gestational age on the estimates of efficacy 3.) Examine the impact of the numbers of painful procedures the infant experiences and the concurrent use of analgesic medications on the estimates of efficacy

Conditions

  • Preterm Infants

Interventions

PROCEDURE

25% Sucrose

orally administrated 25%Sucrose before, during and after heel stick

PROCEDURE

facilitated tucking

facilitated tucking before, during and after heel stick

PROCEDURE

Sucrose and facilitated tucking

orally administrated 25%sucrose and facilitated tucking before, during and after heel stick

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • University Hospital, Zürich

    collaborator OTHER

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • University of Basel

    lead OTHER

Principal Investigators

  • Eva EC Cignacco, PhD,MNSc, RM · Institute of Nursing Science, medical Faculty, University of Basel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
15 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Switzerland

Study Locations

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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 NCT00758511 on ClinicalTrials.gov