Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
Overview
- Phase
- Phase 4
- Intervention
- sucrose 24% oral solution
- Conditions
- Procedural Pain
- Sponsor
- Children's Hospital of Michigan
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- skin blood flow response (perfusion units, PU)
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to assess whether an instrument, the Laser Doppler Imager, is able to measure the effect of pain related changes in skin blood flow in newborn infants. The study will also determine whether the use of sucrose (sugar water) when given by mouth has any effect on pain related skin blood flow changes.
Detailed Description
During the last 25 years evidence that newborns can experience pain has been increasing. Painful procedures (injections, heel lances, and circumcisions) are part of normal routine newborn care. Studies have demonstrated that newborns have increased sensitivity to pain when compared with older children and adults. Pain assessment and management is an important component in the overall care of the newborn infant and safe, effective analgesics are needed. Pain assessment is complicated by the infants' verbal and cognitive limitations. Heart rate, blood pressure and oxygen saturation are commonly monitored in the nursery in response to pain, yet these parameters are affected by handling, illness, medications, as well as by pain. Skin blood flow has been documented to increase in premature newborns undergoing painful procedures in the Newborn Intensive Care Nursery. In the present study, Laser Doppler Imager technology will be used to define changes in skin blood flow response to heel lance and oral sucrose administration in normal newborn infants.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent from parent or legal guardian.
- •Term, newborn infant, between 1 and 7 days of age.
- •Appropriate for gestational age (weight 5th through 95th percentile).
Exclusion Criteria
- •Small or large for gestational age (weight\<5th or \>95th percentile).
- •Physical or biochemical abnormalities.
- •History of maternal drug dependence.
- •Apgar score \<7 at 5 minutes.
- •Current use of analgesics.
Arms & Interventions
1
2 ml sucrose 25% oral solution one time only dose by mouth
Intervention: sucrose 24% oral solution
2
sterile water 2 ml one time only dose given by mouth prior to heel lance
Intervention: sterile water
Outcomes
Primary Outcomes
skin blood flow response (perfusion units, PU)
Time Frame: immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points)
Secondary Outcomes
- Heart rate(10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance)
- Blood pressure(10 minutes prior to heel lance, 5 minutes after heel lance)
- Respiratory rate(10 minutes prior to heel lance, immediatel prior to heel lance, at time of heel lance, 5 minutes post end heel lance)
- axillary temperature(10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance)
- oxygen saturation (SaO2)(10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance)
- Neonatal Infant Pain Score(10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance)