June 4, 2008 |
June 9, 2008 |
September 2005 |
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 ] |
Same as current |
Complete list of historical versions of study NCT00694174 on ClinicalTrials.gov Archive Site |
- 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 ]
|
Same as current |
|
Skin Blood Flow Changes Using Laser Doppler Imager for Assessment of Pain and Analgesia in Newborn Infants |
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. |
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. |
Phase IV |
Interventional |
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Procedural Pain |
- Drug: sucrose 24% oral solution
- Drug: sterile water
|
- Active Comparator: 2 ml sucrose 25% oral solution one time only dose by mouth
- Placebo Comparator: sterile water 2 ml one time only dose given by mouth prior to heel lance
|
- 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.
|
|
Completed |
56 |
September 2007 |
September 2007 (final data collection date for primary outcome measure) |
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.
|
Both |
up to 7 Days |
No |
|
United States |
|
|
NCT00694174 |
Victoria Tutag Lehr, Pharm.D., Children's Hospital of Michigan, The Detroit Medical Center |
|
Children's Hospital of Michigan |
|
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 |
|
|
Children's Hospital of Michigan |
June 2008 |