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

Sponsored by:	Children's Hospital of Michigan
Information provided by:	Children's Hospital of Michigan
ClinicalTrials.gov Identifier:	NCT00694174

Purpose

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.

Condition	Intervention	Phase
Procedural Pain	Drug: sucrose 24% oral solution Drug: sterile water	Phase IV

MedlinePlus related topics: Drinking Water

Drug Information available for: Sucrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants

Further study details as provided by Children's Hospital of Michigan:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Heart rate [ Time Frame: 10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 10 minutes prior to heel lance, 5 minutes after heel lance ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	56
Study Start Date:	September 2005
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 2 ml sucrose 25% oral solution one time only dose by mouth	Drug: sucrose 24% oral solution sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance
2: Placebo Comparator sterile water 2 ml one time only dose given by mouth prior to heel lance	Drug: sterile water sterile water 2 ml single dose to be administered orally one time prior to heel lance

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

Ages Eligible for Study:	up to 7 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694174

Locations

United States, Michigan
Hutzel Women's University Hospital, The Detroit Medical Center
Detroit, Michigan, United States, 48201

Sponsors and Collaborators

Children's Hospital of Michigan

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

More Information

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.

Holland AJ, Martin HC, Cass DT. Laser Doppler imaging prediction of burn wound outcome in children. Burns. 2002 Feb;28(1):11-7.

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.

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.

McCulloch KM, Ji SA, Raju TN. Skin blood flow changes during routine nursery procedures. Early Hum Dev. 1995 Apr 14;41(2):147-56.

Bonamy AK, Martin H, Jörneskog 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. 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. Review.

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.

Responsible Party:	Children's Hospital of Michigan, The Detroit Medical Center ( Victoria Tutag Lehr, Pharm.D. )
Study ID Numbers:	027505MP4F
Study First Received:	June 4, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00694174
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Michigan:

Procedural Pain in Newborn Infants
newborn infant
acute procedural pain
skin blood flow changes

sucrose analgesia
laser doppler imager
neonatal infant pain scale

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009