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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01289808
Enrollment
180
Registered
2011-02-04
Start date
2011-02-28
Completion date
2011-07-31
Last updated
2012-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn Diseases

Keywords

Glucose, analgesic, newborns

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.

Interventions

1ml of glucose 25% once

Sponsors

The Baruch Padeh Medical Center, Poriya
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Days to 16 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Reduced infant response to a routine care procedure after glucose 25% analgesia30 minutesAn 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026