Sucrose Analgesia in Infants Undergoing Casting for Club Foot

Rabin Medical Center20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Clubfoot

Interventions

sucrose solutionDIETARY_SUPPLEMENT

5cc 5% sucrose solution P/O

SalineDIETARY_SUPPLEMENT

5cc saline p/o

Eligibility

Sex: ALLMin age: 4 WeeksMax age: 12 Months

Medical Language ↔ Plain English

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.

Locations (1)

Schneider Children's Medical Center

Petah Tikva, Israel

Outcomes

Primary Outcomes

Pulse rate, Blood oxygenation

Time frame: During casting

Central Contacts

Daniel M Weigl, MD

CONTACT

972-3-9253759 danielw@clalit.org.il

Data from ClinicalTrials.gov

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