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A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants

NCT02395185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-12-15

Study results available
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Summary

While it has been shown that sucrose or milk ingestion decreases pain responses in heel sticks, no study up to this point has determined the best intervention for decreasing the pain response during casting for clubfoot deformity.

The goal of this study is to investigate the effect of three different non-pharmacologic interventions (sucrose, milk, water) on pain response during clubfoot casting.

This study will allow us to discern the best non-pharmacologic intervention for pain control during clubfoot casting and to provide a more pleasant, comfortable experience for patients and families.

Conditions

  • Clubfoot

Interventions

OTHER

Milk bottle administration

Patients are given a bottle of milk during the casting process.

OTHER

Water bottle administration

Patients are given a bottle of water during the casting process.

OTHER

Sucrose bottle administration

Patients are given a bottle of sucrose during the casting process.

Sponsors & Collaborators

  • Kosair Charities, Inc.

    collaborator OTHER

  • University of Kentucky

    collaborator OTHER

  • Shriners Hospitals for Children

    lead OTHER

Principal Investigators

  • Todd M Milbrandt, MD · Shriners Hospital for Children, Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-10-31
Completion
2014-10-31

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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 NCT02395185 on ClinicalTrials.gov