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Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1

NCT01514253 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2012-01-23

No results posted yet for this study

Summary

Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.

Conditions

  • Infant, Newborn, Diseases

Interventions

DRUG

Glucose 25%

1 ml glucose 25%, once

DIETARY_SUPPLEMENT

Materna RTF Stage 1

1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.

OTHER

Water for Injection

1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination

Sponsors & Collaborators

  • The Baruch Padeh Medical Center, Poriya

    lead OTHER_GOV

Principal Investigators

  • Shay Barak, MD · The Baruch Pade Medical Center - Poriya

  • Amir Kushnir, MD · The Baruch Padeh Medical Center - Poria

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Max Age
16 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • Israel

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 NCT01514253 on ClinicalTrials.gov