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

NCT ID: NCT00694174

Last Updated: 2008-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-09-30

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.

Conditions

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Procedural Pain

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

2 ml sucrose 25% oral solution one time only dose by mouth

Group Type ACTIVE_COMPARATOR

sucrose 24% oral solution

Intervention Type DRUG

sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance

2

sterile water 2 ml one time only dose given by mouth prior to heel lance

Group Type PLACEBO_COMPARATOR

sterile water

Intervention Type DRUG

sterile water 2 ml single dose to be administered orally one time prior to heel lance

Interventions

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sucrose 24% oral solution

sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance

Intervention Type DRUG

sterile water

sterile water 2 ml single dose to be administered orally one time prior to heel lance

Intervention Type DRUG

Other Intervention Names

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Oral sucrose solution sterile water U.S.P.

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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Children's Hospital of Michigan, The Detroit Medical Center

Principal Investigators

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Victoria Tutag Lehr, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Michigan, The Detroit Medical Center, Wayne State University

Josef Cortez, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hutzel Women's University Hospital, The Detroit Medical Center, Wayne State University

Locations

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Hutzel Women's University Hospital, The Detroit Medical Center

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 17545383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11834324 (View on PubMed)

Johnston CC, Stevens BJ. Experience in a neonatal intensive care unit affects pain response. Pediatrics. 1996 Nov;98(5):925-30.

Reference Type BACKGROUND
PMID: 8909487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8358144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8916058 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7601018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17986202 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16117989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16777824 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24918475 (View on PubMed)

Other Identifiers

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027505MP4F

Identifier Type: -

Identifier Source: org_study_id