Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Analgesia
- Sponsor
- IRCCS Burlo Garofolo
- Enrollment
- 80
- Primary Endpoint
- Cortical oxy-haemoglobin increase
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Full term healthy infants, needing a heel-prick for metabolic screening;
- •Informed consent obtained from parents.
Exclusion Criteria
- •Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)
Outcomes
Primary Outcomes
Cortical oxy-haemoglobin increase
Time Frame: During the procedure
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2)
Secondary Outcomes
- Neonatal Infant Pain Scale (NIPS)(During the procedure)