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Sucrose Analgesia in Infants Undergoing Casting for Club Foot

NCT ID: NCT01050088

Last Updated: 2010-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-03-31

Brief Summary

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Babies with congenital clubfeet are treated by the Ponseti casting method. The procedure may cause discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies.

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Detailed Description

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Babies who were born with congenital clubfeet are currently being treated by the conventional Ponseti method. This procedure is done in an outpatient clinic setup. The procedure is painless but may cause some discomfort to the patient. This study will examine the use of 5 CC Sucrose solution as a comforting agent for the babies. The control group will consist of patients who will get 5cc saline pre cast application, while the study group will be given 5cc of Sucrose solution. Patients and physicians are blinded to the treatment they get. Outcome measures will include pulse rate and oxygenation as an accepted measure of discomfort.

Conditions

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Clubfoot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sucrose

5cc sucrose solution

Group Type EXPERIMENTAL

sucrose solution

Intervention Type DIETARY_SUPPLEMENT

5cc 5% sucrose solution P/O

Saline

5cc saline p/o

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DIETARY_SUPPLEMENT

5cc saline p/o

Interventions

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sucrose solution

5cc 5% sucrose solution P/O

Intervention Type DIETARY_SUPPLEMENT

Saline

5cc saline p/o

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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5cc Saline solution

Eligibility Criteria

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Inclusion Criteria

* All otherwise healthy babies who need casting for congenital clubfeet

Exclusion Criteria

* All non idiopathic conditions for clubfoot, all individuals who have any kind of known systemic illness, all babies born to diabetic mothers.
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Schneider Children's MedicalCenter in Israel

Principal Investigators

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Danielw M Weigl, MD

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center

Kalman Katz, Prof.

Role: STUDY_DIRECTOR

Schneider Children's Medical Center

Locations

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Schneider Children's Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Daniel M Weigl, MD

Role: CONTACT

[email protected]
972-3-9253759

Facility Contacts

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Daniel M Weigl, MD

Role: primary

[email protected]
972-3-9253759

Other Identifiers

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005411

Identifier Type: -

Identifier Source: org_study_id

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