Trial record 8 of 21 for:    "Talipes equinovarus"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01050088
First received: January 14, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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
Clubfoot
Dietary Supplement: sucrose solution
Dietary Supplement: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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

Keywords provided by Rabin Medical Center:
clubfoot
casting
ponseti
discomfort

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired

ClinicalTrials.gov processed this record on April 22, 2014