NCT01050088

Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 4 Weeks – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Clubfoot

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	sucrose solution	5cc 5% sucrose solution P/O
DIETARY_SUPPLEMENT	Saline	5cc saline p/o

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-09-01
• Completion: 2011-03-01
• First posted: 2010-01-15
• Last updated: 2010-01-15

Locations

1 site across 1 country: Israel