SCF: Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01050088

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Clubfoot	Dietary Supplement: sucrose solution Dietary Supplement: Saline	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Study Start Date :

Mar 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2010

Anticipated Study Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sucrose 5cc sucrose solution	Dietary Supplement: sucrose solution 5cc 5% sucrose solution P/O
Placebo Comparator: Saline 5cc saline p/o	Dietary Supplement: Saline 5cc saline p/o Other Names: 5cc Saline solution

Arm

Intervention/Treatment

Experimental: Sucrose

5cc sucrose solution

Dietary Supplement: sucrose solution

5cc 5% sucrose solution P/O

Placebo Comparator: Saline

5cc saline p/o

Dietary Supplement: Saline

5cc saline p/o

Other Names:

5cc Saline solution

Outcome Measures

Primary Outcome Measures

Pulse rate, Blood oxygenation [During casting]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Weeks to 12 Months

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schneider Children's Medical Center	Petach Tikva		Israel

Sponsors and Collaborators

Rabin Medical Center

Investigators

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