Sucrose Analgesia in Infants Undergoing Casting for Club... | NCT01050088

Studies
Sucrose Analgesia in Infants Undergoing Casting for Club Foot

NCT01050088

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Jan 15, 2010Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Clubfoot

Interventions

sucrose solution
Saline

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Sep 2010Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Jan 14, 2010

First Posted Date

Jan 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2010

Last Update Posted Date

Jan 15, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sucrose	Experimental	5cc sucrose solution	Dietary Supplement: sucrose solution
Saline	Placebo Comparator	5cc saline p/o	Dietary Supplement: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sucrose solution	Dietary Supplement	5cc 5% sucrose solution P/O	Sucrose

Measure	Description	Time Frame
Pulse rate, Blood oxygenation		During casting

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Weeks

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel M Weigl, MD	Contact	972-3-9253759		danielw@clalit.org.il

Overall Officials

Name	Affiliation	Role
Danielw M Weigl, MD	Schneider Children's Medical Center	Principal Investigator
Kalman Katz, Prof.	Schneider Children's Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schneider Children's Medical Center		Petah Tikva			Israel

Condition Browse Module

MeSH Terms

ID	Term
D003025	Clubfoot

Ancestor Terms

ID	Term
D000070558	Talipes
D005531	Foot Deformities, Acquired
D005530	Foot Deformities
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C067074	sodium lactobionate sucrose solution
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided