Effectiveness of Sucrose Analgesia in Infants Undergoing Casting for Club Foot
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rabin Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Pulse rate, Blood oxygenation
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 4 Weeks to 12 Months (Child)
- Sex
- 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.
Arms & Interventions
Sucrose
5cc sucrose solution
Intervention: sucrose solution (Dietary Supplement)
Saline
5cc saline p/o
Intervention: Saline (Dietary Supplement)
Outcomes
Primary Outcomes
Pulse rate, Blood oxygenation
Time Frame: During casting
Secondary Outcomes
No secondary outcomes reported