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

Primary Purpose

Procedural Pain

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

sucrose 24% oral solution

sterile water

About this trial

This is an interventional treatment trial for Procedural Pain focused on measuring Procedural Pain in Newborn Infants, newborn infant, acute procedural pain, skin blood flow changes, sucrose analgesia, laser doppler imager, neonatal infant pain scale

Eligibility Criteria

1 Day - 7 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hutzel Women's University Hospital, The Detroit Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

skin blood flow response (perfusion units, PU)

Secondary Outcome Measures

Heart rate

Blood pressure

Respiratory rate

axillary temperature

oxygen saturation (SaO2)

Neonatal Infant Pain Score

Full Information

NCT ID

NCT00694174

First Posted

June 4, 2008

Last Updated

June 9, 2008

Sponsor

Children's Hospital of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT00694174

Brief Title

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

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Children's Hospital of Michigan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

sucrose 24% oral solution

Other Intervention Name(s)

Oral sucrose solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

sterile water

Other Intervention Name(s)

sterile water U.S.P.

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Heart rate

Time Frame

10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance

Title

Blood pressure

Time Frame

10 minutes prior to heel lance, 5 minutes after heel lance

Title

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

Title

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

Title

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

Title

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. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

7 Days

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victoria Tutag Lehr, Pharm.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Josef Cortez, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hutzel Women's University Hospital, The Detroit Medical Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17545383

Citation

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.

Results Reference

background

PubMed Identifier

11834324

Citation

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.

Results Reference

background

PubMed Identifier

8909487

Citation

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

Results Reference

background

PubMed Identifier

8358144

Citation

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.

Results Reference

background

PubMed Identifier

8916058

Citation

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.

Results Reference

background

PubMed Identifier

7601018

Citation

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.

Results Reference

background

PubMed Identifier

17986202

Citation

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.

Results Reference

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PubMed Identifier

16117989

Citation

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.

Results Reference

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PubMed Identifier

16777824

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.

Results Reference

background

PubMed Identifier

24918475

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.

Results Reference

derived

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

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