Clinical Trial: Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Rabin Medical Center

Current Primary Outcome: Pulse rate, Blood oxygenation [ Time Frame: During casting ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rabin Medical Center

Dates:
Date Received: January 14, 2010
Date Started: March 2010
Date Completion: March 2011
Last Updated: January 14, 2010
Last Verified: January 2010