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

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital of Michigan
ClinicalTrials.gov Identifier:
NCT00694174
First received: June 4, 2008
Last updated: June 9, 2008
Last verified: June 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants

Resource links provided by NLM:


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
Active Comparator: 1
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
Other Name: Oral sucrose solution
Placebo Comparator: 2
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
Other Name: sterile water U.S.P.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Responsible Party: Victoria Tutag Lehr, Pharm.D., Children's Hospital of Michigan, The Detroit Medical Center
ClinicalTrials.gov Identifier: NCT00694174     History of Changes
Other Study ID Numbers: 027505MP4F
Study First Received: June 4, 2008
Last Updated: June 9, 2008
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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014