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

NCT01289808 | Terminated

• 1 other identifier: SAOR 005.CTIL
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infant; Newborn Diseases

Keywords

Glucose; analgesic; newborns

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

glucose 25%

EXPERIMENTAL

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%

Interventions

Glucose 25% DRUG

1ml of glucose 25% once

Also known as: Water for injection

glucose 25%

Eligibility Criteria

• Age: 1 Day - 16 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Full term above 37 weeks gestation.
• Normal birth-weight, healthy infants
• Males and Females
• Whose parents have signed the informed consent form

You may not qualify if:

• Premature born below 37 weeks
• Chromosomal abnormalities or congenital malformation.
• Suffering neurological imbalance
• Inability of oral feeding

Sponsors & Collaborators

• The Baruch Padeh Medical Center, Poriya: lead

MeSH Terms

Interventions

Water; Injections

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Shay Barak, MD

  Neonatal Department, The Baruch Padeh Medical center - Poria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Neonatologist

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: February 4, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 9, 2012

Record last verified: 2012-01