Clubfoot
Conditions
Keywords
clubfoot, casting, ponseti, discomfort
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.
Interventions
DIETARY_SUPPLEMENTsucrose solution
5cc 5% sucrose solution P/O
DIETARY_SUPPLEMENTSaline
5cc saline p/o
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 12 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulse rate, Blood oxygenation | During casting |
Countries
Israel
Contacts
Primary ContactDaniel M Weigl, MD
Outcome results
None listed