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Completed

NCT Number: NCT00694174

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

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.

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Key information

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hutzel Women's University Hospital, The Detroit Medical Center

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sucrose 24% oral solution

Drug

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

Other names: Oral sucrose solution

Sterile water

Drug

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

Other names: sterile water U.S.P.

Primary outcomes

  1. 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 outcomes

  1. Heart rate

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

  2. Blood pressure

    Time frame: 10 minutes prior to heel lance, 5 minutes after heel lance

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Michigan

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 10, 2008
Registry last updated
Jun 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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