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Sucrose Analgesia in Infants Undergoing Casting for Club Foot (SCF)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by:
Rabin Medical Center Identifier:
First received: January 14, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
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.

Condition Intervention
Dietary Supplement: sucrose solution
Dietary Supplement: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Resource links provided by NLM:

Further study details as provided by Rabin Medical Center:

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

Estimated Enrollment: 20
Study Start Date: March 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sucrose
5cc sucrose solution
Dietary Supplement: sucrose solution
5cc 5% sucrose solution P/O
Placebo Comparator: Saline
5cc saline p/o
Dietary Supplement: Saline
5cc saline p/o
Other Name: 5cc Saline solution

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.

Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01050088

Contact: Daniel M Weigl, MD 972-3-9253759

Schneider Children's Medical Center Not yet recruiting
Petach Tikva, Israel
Contact: Daniel M Weigl, MD    972-3-9253759   
Principal Investigator: Daniel M Weigl, MD         
Sponsors and Collaborators
Rabin Medical Center
Principal Investigator: Danielw M Weigl, MD Schneider Children's Medical Center
Study Director: Kalman Katz, Prof. Schneider Children's Medical Center
  More Information

Responsible Party: Weigl Daniel MD, Schneider Children's MedicalCenter in Israel Identifier: NCT01050088     History of Changes
Other Study ID Numbers: 005411
Study First Received: January 14, 2010
Last Updated: January 14, 2010

Keywords provided by Rabin Medical Center:

Additional relevant MeSH terms:
Equinus Deformity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Foot Deformities, Acquired
Pharmaceutical Solutions processed this record on May 24, 2017