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

Procedural Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694174
• Other study ID #: 027505MP4F
• Status: Completed
• Phase: Phase 4
• First received: June 4, 2008
• Last updated: June 9, 2008
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: June 2008
• Source: Children's Hospital of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Procedural Pain

Intervention

Drug:
• sucrose 24% oral solution
sucrose 24% oral solution 2 ml one time only dose administered by mouth prior to heel lance
• sterile water
sterile water 2 ml single dose to be administered orally one time prior to heel lance

Locations

Country	Name	City	State
United States	Hutzel Women's University Hospital, The Detroit Medical Center	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. Review. — View Citation

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. — View Citation

Gonsalves S, Mercer J. Physiological correlates of painful stimulation in preterm infants. Clin J Pain. 1993 Jun;9(2):88-93. — View Citation

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	skin blood flow response (perfusion units, PU)		immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points)	No
Secondary	Heart rate		10 minutes prior to heel lance, immediately prior to heel lance, at heel lance, 5 minutes post end heel lance	No
Secondary	Blood pressure		10 minutes prior to heel lance, 5 minutes after heel lance	Yes
Secondary	Respiratory rate		10 minutes prior to heel lance, immediatel prior to heel lance, at time of heel lance, 5 minutes post end heel lance	No
Secondary	axillary temperature		10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance	Yes
Secondary	oxygen saturation (SaO2)		10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance	No
Secondary	Neonatal Infant Pain Score		10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance	No