Sucrose Analgesia in Infants Undergoing Casting for Club Foot (SCF)
Recruitment status was Not yet recruiting
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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 |
- 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 |
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| Contact: Daniel M Weigl, MD | 972-3-9253759 | danielw@clalit.org.il |
| 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 | |
| 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 June 17, 2013