Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants

Conditions
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Procedural Pain

Intervention / Treatment
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* Drug: sucrose 24% oral solution
* Drug: sterile water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>2 ml sucrose 25% oral solution one time only dose by mouth | Drug: sucrose 24% oral solution<br>* sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance<br>* Other names: Oral sucrose solution;|
| Placebo Comparator: 2<br>sterile water 2 ml one time only dose given by mouth prior to heel lance | Drug: sterile water<br>* sterile water 2 ml single dose to be administered orally one time prior to heel lance<br>* Other names: sterile water U.S.P.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin blood flow response (perfusion units, PU) |  | immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procedural Pain in Newborn Infants, newborn infant, acute procedural pain, skin blood flow changes, sucrose analgesia, laser doppler imager, neonatal infant pain scale