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Sucrose Analgesia in Infants Undergoing Casting for Club Foot (SCF)

Primary Purpose

Clubfoot

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

sucrose solution

Saline

About this trial

This is an interventional supportive care trial for Clubfoot focused on measuring clubfoot, casting, ponseti, discomfort

Eligibility Criteria

4 Weeks - 12 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Schneider Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sucrose

Saline

Arm Description

5cc sucrose solution

5cc saline p/o

Outcomes

Primary Outcome Measures

Pulse rate, Blood oxygenation

Secondary Outcome Measures

Full Information

NCT ID

NCT01050088

First Posted

January 14, 2010

Last Updated

January 14, 2010

Sponsor

Rabin Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01050088

Brief Title

Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Acronym

SCF

Official Title

Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

March 2010 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Rabin Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clubfoot

Keywords

clubfoot, casting, ponseti, discomfort

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sucrose

Arm Type

Experimental

Arm Description

5cc sucrose solution

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

5cc saline p/o

Intervention Type

Dietary Supplement

Intervention Name(s)

sucrose solution

Intervention Description

5cc 5% sucrose solution P/O

Intervention Type

Dietary Supplement

Intervention Name(s)

Saline

Other Intervention Name(s)

5cc Saline solution

Intervention Description

5cc saline p/o

Primary Outcome Measure Information:

Title

Pulse rate, Blood oxygenation

Time Frame

During casting

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Weeks

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel M Weigl, MD

Phone

972-3-9253759

danielw@clalit.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danielw M Weigl, MD

Organizational Affiliation

Schneider Children's Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kalman Katz, Prof.

Organizational Affiliation

Schneider Children's Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Schneider Children's Medical Center

City

Petach Tikva

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel M Weigl, MD

Phone

972-3-9253759

danielw@clalit.org.il

First Name & Middle Initial & Last Name & Degree

Daniel M Weigl, MD

12. IPD Sharing Statement

Learn more about this trial

Sucrose Analgesia in Infants Undergoing Casting for Club Foot

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