Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia
Overview
- Phase
- N/A
- Intervention
- Glucose 25%
- Conditions
- Infant
- Sponsor
- The Baruch Padeh Medical Center, Poriya
- Enrollment
- 180
- Primary Endpoint
- Reduced infant response to a routine care procedure after glucose 25% analgesia
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Shay Barak
Senior Neonatologist
The Baruch Padeh Medical Center, Poriya
Eligibility Criteria
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
Arms & Interventions
glucose 25%
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
Intervention: Glucose 25%
Outcomes
Primary Outcomes
Reduced infant response to a routine care procedure after glucose 25% analgesia
Time Frame: 30 minutes
An observer nurse will focus on the infant's facial expression. A score between 0 and 3 will be assigned for each of the three facial expression indicators. For physiological data, infants will be monitored for changes in heart rate and oxygen saturation using a transcutaneous pulse oximeter. A score between 0 and 3 will be assigned for each of the physiological indicators