Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants
June 9, 2008 updated by: Children's Hospital of Michigan
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Hutzel Women's University Hospital, The Detroit Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 1 week (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: 1
2 ml sucrose 25% oral solution one time only dose by mouth
|
sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance
Other Names:
|
|
PLACEBO_COMPARATOR: 2
sterile water 2 ml one time only dose given by mouth prior to heel lance
|
sterile water 2 ml single dose to be administered orally one time prior to heel lance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Heart rate
Time Frame: 10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance
|
10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance
|
|
Blood pressure
Time Frame: 10 minutes prior to heel lance, 5 minutes after heel lance
|
10 minutes prior to heel lance, 5 minutes after heel lance
|
|
Respiratory rate
Time Frame: 10 minutes prior to heel lance, immediatel prior to heel lance, at time of heel lance, 5 minutes post end heel lance
|
10 minutes prior to heel lance, immediatel prior to heel lance, at time of heel lance, 5 minutes post end heel lance
|
|
axillary temperature
Time Frame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
|
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)
Time Frame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
|
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
Time Frame: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
|
10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Victoria Tutag Lehr, Pharm.D., Children's Hospital of Michigan, The Detroit Medical Center, Wayne State University
- Principal Investigator: Josef Cortez, M.D., Hutzel Women's University Hospital, The Detroit Medical Center, Wayne State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Martin H, Lindblad B, Norman M. Endothelial function in newborn infants is related to folate levels and birth weight. Pediatrics. 2007 Jun;119(6):1152-8. doi: 10.1542/peds.2006-2706.
- Holland AJ, Martin HC, Cass DT. Laser Doppler imaging prediction of burn wound outcome in children. Burns. 2002 Feb;28(1):11-7. doi: 10.1016/s0305-4179(01)00064-x.
- Johnston CC, Stevens BJ. Experience in a neonatal intensive care unit affects pain response. Pediatrics. 1996 Nov;98(5):925-30.
- Gonsalves S, Mercer J. Physiological correlates of painful stimulation in preterm infants. Clin J Pain. 1993 Jun;9(2):88-93. doi: 10.1097/00002508-199306000-00003.
- Moustogiannis AN, Raju TN, Roohey T, McCulloch KM. Intravenous morphine attenuates pain induced changes in skin blood flow in newborn infants. Neurol Res. 1996 Oct;18(5):440-4. doi: 10.1080/01616412.1996.11740448.
- McCulloch KM, Ji SA, Raju TN. Skin blood flow changes during routine nursery procedures. Early Hum Dev. 1995 Apr 14;41(2):147-56. doi: 10.1016/0378-3782(95)01617-c.
- Bonamy AK, Martin H, Jorneskog G, Norman M. Lower skin capillary density, normal endothelial function and higher blood pressure in children born preterm. J Intern Med. 2007 Dec;262(6):635-42. doi: 10.1111/j.1365-2796.2007.01868.x. Epub 2007 Nov 7.
- Anand KJ, Johnston CC, Oberlander TF, Taddio A, Lehr VT, Walco GA. Analgesia and local anesthesia during invasive procedures in the neonate. Clin Ther. 2005 Jun;27(6):844-76. doi: 10.1016/j.clinthera.2005.06.018.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (ACTUAL)
September 1, 2007
Study Completion (ACTUAL)
September 1, 2007
Study Registration Dates
First Submitted
June 4, 2008
First Submitted That Met QC Criteria
June 9, 2008
First Posted (ESTIMATE)
June 10, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
June 10, 2008
Last Update Submitted That Met QC Criteria
June 9, 2008
Last Verified
June 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 027505MP4F
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