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

Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01289808
• Other study ID #: SAOR 005.CTIL
• Status: Terminated
• Phase: N/A
• First received: January 27, 2011
• Last updated: January 6, 2012
• Start date: February 2011
• Est. completion date: July 2011

Study information

• Verified date: January 2012
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: July 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infant
• Newborn Diseases

Intervention

Drug:
• Glucose 25%
1ml of glucose 25% once
• Glucose 25%
1ml glucose once per os

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No