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

Not Applicable

Terminated

• Conditions: Infant; Newborn Diseases
• Interventions: Drug: Glucose 25%

• Registration Number: NCT01289808
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

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.

Study Timeline

• Study First Submitted: 2011-01-27
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-04
• Primary Completion: 2011-05
• Study Completion: 2011-07
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-06
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
glucose 25%	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

Primary Outcome Measures

Name	Time	Method
Reduced infant response to a routine care procedure after glucose 25% analgesia	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