Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Clubfoot Clinical Trial

— SCF  

Official title:

Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01050088
• Other study ID #: 005411
• Status: Not yet recruiting
• Phase: N/A
• First received: January 14, 2010
• Last updated: January 14, 2010
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: January 2010
• Source: Rabin Medical Center
• Contact: Daniel M Weigl, MD
• Phone: 972-3-9253759
• Email: danielw[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

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

Related Conditions & MeSH terms

• Clubfoot

Intervention

Dietary Supplement:
• sucrose solution
5cc 5% sucrose solution P/O
• Saline
5cc saline p/o

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse rate, Blood oxygenation		During casting	No