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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infant, Newborn Diseases

Intervention / Treatment
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* Drug: Glucose 25%
* Drug: Glucose 25%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 16 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glucose 25%<br>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 | Drug: Glucose 25%<br>* 1ml of glucose 25% once<br>* Other names: Water for injection;Drug: Glucose 25%<br>* 1ml glucose once per os<br>* Other names: water for injection once per os;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced infant response to a routine care procedure after glucose 25% analgesia | 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 | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose, analgesic, newborns