Sucrose Analgesia in Infants Undergoing Casting for Club Foot — SCF  

Clubfoot Clinical Trial

Official title: Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Clubfoot

• NCT number: NCT01050088
• Study type: Interventional
• Source: Rabin Medical Center
• Contact: Daniel M Weigl, MD
• Phone: 972-3-9253759
• Email: danielw@clalit.org.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2010
• Completion date: March 2011