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

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ClinicalTrials.gov Identifier: NCT01050088
Recruitment Status : Unknown
Verified January 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 15, 2010
Last Update Posted : January 15, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Clubfoot Dietary Supplement: sucrose solution Dietary Supplement: Saline Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot
Study Start Date : March 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health
Drug Information available for: Sucrose

Arm Intervention/treatment
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




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


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050088


Contacts
Contact: Daniel M Weigl, MD 972-3-9253759 danielw@clalit.org.il

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

Responsible Party: Weigl Daniel MD, Schneider Children's MedicalCenter in Israel
ClinicalTrials.gov Identifier: NCT01050088     History of Changes
Other Study ID Numbers: 005411
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

Keywords provided by Rabin Medical Center:
clubfoot
casting
ponseti
discomfort

Additional relevant MeSH terms:
Clubfoot
Talipes
Equinus Deformity
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Pharmaceutical Solutions