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

Clalit Health Services

Status: Unknown

Conditions: Clubfoot

Treatments: Dietary Supplement: sucrose solution; Dietary Supplement: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01050088

005411

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 4 weeks to 12 months old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Sucrose

Experimental group

Description:

5cc sucrose solution

Treatment:

Dietary Supplement: sucrose solution

Saline

Placebo Comparator group

Description:

5cc saline p/o

Treatment:

Dietary Supplement: Saline