Clinical trial NCT00694174: Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
Official title: Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Procedural Pain
Keywords: Procedural Pain in Newborn Infants
newborn infant
acute procedural pain
skin blood flow changes
sucrose analgesia
laser doppler imager
neonatal infant pain scale
Lead sponsor: Children's Hospital of Michigan
Sponsor class: OTHER
First posted: 2008-06-10
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: skin blood flow response (perfusion units, PU)
timeFrame: immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points)
Secondary outcomes:
measure: Heart rate
timeFrame: 10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance
measure: Blood pressure
timeFrame: 10 minutes prior to heel lance, 5 minutes after heel lance
measure: Respiratory rate
timeFrame: 10 minutes prior to heel lance, immediatel prior to heel lance, at time of heel lance, 5 minutes post end heel lance
measure: axillary temperature
timeFrame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
measure: oxygen saturation (SaO2)
timeFrame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
measure: Neonatal Infant Pain Score
timeFrame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Hutzel Women's University Hospital, The Detroit Medical Center
state: Michigan
Study officials:
affiliation: Children's Hospital of Michigan, The Detroit Medical Center, Wayne State University
name: Victoria Tutag Lehr, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hutzel Women's University Hospital, The Detroit Medical Center, Wayne State University
name: Josef Cortez, M.D.
role: PRINCIPAL_INVESTIGATOR
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citation: Anand KJ, Aranda JV, Berde CB, Buckman S, Capparelli EV, Carlo W, Hummel P, Johnston CC, Lantos J, Tutag-Lehr V, Lynn AM, Maxwell LG, Oberlander TF, Raju TN, Soriano SG, Taddio A, Walco GA. Summary proceedings from the neonatal pain-control group. Pediatrics. 2006 Mar;117(3 Pt 2):S9-S22. doi: 10.1542/peds.2005-0620C.
citation: Tutag Lehr V, Cortez J, Grever W, Cepeda E, Thomas R, Aranda JV. Randomized placebo-controlled trial of sucrose analgesia on neonatal skin blood flow and pain response during heel lance. Clin J Pain. 2015 May;31(5):451-8. doi: 10.1097/AJP.0000000000000126.