Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Not Applicable

• Conditions: Clubfoot
• Interventions: Dietary Supplement: sucrose solution; Dietary Supplement: Saline

• Registration Number: NCT01050088
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Status Verified: 2010-01
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-14
• Last Update Submitted: 2010-01-14
• Study First Posted: 2010-01-15
• Last Update Posted: 2010-01-15
• Study Start: 2010-03
• Primary Completion: 2010-09
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sucrose	sucrose solution	5cc sucrose solution
Saline	Saline	5cc saline p/o

Primary Outcome Measures

Name	Time	Method
Pulse rate, Blood oxygenation	During casting

Trial Locations

Locations (1)

Schneider Children's Medical Center; 🇮🇱 Petach Tikva, Israel