Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia

Baruch Padeh Medical Center

Status: Terminated

Conditions: Newborn Diseases; Infant

Treatments: Drug: Glucose 25%

Study type: Interventional

Funder types: Other

Identifiers

NCT01289808

SAOR 005.CTIL

Details and patient eligibility

About

Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. The investigators objective is to determine the effect of glucose 25% analgesia for procedural pain on infant pain responses during a subsequent care giving procedure.

Full description

Pain in the newborn and young infant is a source of stress for the infant, family and care providers.

During hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby.

Pain experienced during the neonatal period is known to have long term effects on the baby.

The red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. The examination causes discomfort to the infant.

Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. Our objective is to determine the effect of glucose 25% analgesia for procedural pain on infant pain responses during a subsequent care giving procedure.

Enrollment: 180 patients

Sex: All

Ages: 1 to 16 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Full term above 37 weeks gestation.
• Normal birth-weight, healthy infants
• Males and Females
• Whose parents have signed the informed consent form

Exclusion criteria

• Premature born below 37 weeks
• Chromosomal abnormalities or congenital malformation.
• Suffering neurological imbalance
• Inability of oral feeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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180 participants in 1 patient group

glucose 25%

Experimental group

Description:

180 healthy babies born term in the Baruch Padeh Medical Center, Poriya. There will be three study groups: Study Group: 60 newborn infants who will receive 1cc 25% Glucose, 2-3 minutes prior red-reflex examination. Base line (control) Group 1: 60 newborn infants who will receive 1cc Water for Injection (WFI), 2-3 minutes prior red-reflex examination. Base line (control ) Group 2: 60 newborn infants who will not receive neither glucose nor Water for Injection (WFI), 2-3 minutes prior red-reflex examination

Treatment:

Drug: Glucose 25%

Drug: Glucose 25%