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

Children's Hospital of Michigan

Status and phase: Completed; Phase 4

Conditions: Procedural Pain

Treatments: Drug: sterile water; Drug: sucrose 24% oral solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00694174

027505MP4F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 1 to 7 days old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: sucrose 24% oral solution

2

Placebo Comparator group

Description:

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

Treatment:

Drug: sterile water