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Procedural PainPhase 4NCT00694174

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

A Phase 4 study testing sucrose 24% oral solution and sterile water in people with Procedural Pain, run by Children's Hospital of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 1 day to 7 days
Conditions the study is for
Procedural Pain
What is being tested?
sucrose 24% oral solution and sterile water
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteUnited States
Study dates
Sep 2005to Sep 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 7 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Hutzel Women's University Hospital, The Detroit Medical Center

    Detroit, Michigan, 48201

Other trials in United States

About this study

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.

Read the 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.

Conditions
Procedural Pain
Being tested
sucrose 24% oral solution, sterile water
Keywords
Procedural Pain in Newborn Infants, newborn infant, acute procedural pain, skin blood flow changes, sucrose analgesia, laser doppler imager, neonatal infant pain scale
Medical subject headings
Pain, Procedural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sucrose 24% oral solutionDrug

    Also called Oral sucrose solution

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

  • sterile waterDrug

    Also called sterile water U.S.P.

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

Study groups in NCT00694174
Study groupRoleWhat they receive
1Active comparator2 ml sucrose 25% oral solution one time only dose by mouth
Receives: Drug: sucrose 24% oral solution
2Placebo comparatorsterile water 2 ml one time only dose given by mouth prior to heel lance
Receives: Drug: sterile water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. skin blood flow response (perfusion units, PU)

    Measured: immediately prior to heel lance, at heel lance, 5 minutes post heel lance (3 time points)

Secondary outcomes (6)

  1. Heart rate

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

  2. Blood pressure

    Measured: 10 minutes prior to heel lance, 5 minutes after heel lance

  3. Respiratory rate

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 10 minutes prior to heel lance, immediately prior to heel lance, at time of heel lance, 5 minutes post end heel lance

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2008 (estimated)
  2. Study startSep 2005
  3. Primary completionSep 2007
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00694174
Sponsor's protocol ID
027505MP4F
Status last verified
Jun 2008
First submitted
4 Jun 2008
Last updated
10 Jun 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • 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. doi: 10.1542/peds.2006-2706.

    PubMed 17545383

  • Holland AJ, Martin HC, Cass DT. Laser Doppler imaging prediction of burn wound outcome in children. Burns. 2002 Feb;28(1):11-7. doi: 10.1016/s0305-4179(01)00064-x.

    PubMed 11834324

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

    PubMed 8909487

  • Gonsalves S, Mercer J. Physiological correlates of painful stimulation in preterm infants. Clin J Pain. 1993 Jun;9(2):88-93. doi: 10.1097/00002508-199306000-00003.

    PubMed 8358144

  • 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. doi: 10.1080/01616412.1996.11740448.

    PubMed 8916058

  • McCulloch KM, Ji SA, Raju TN. Skin blood flow changes during routine nursery procedures. Early Hum Dev. 1995 Apr 14;41(2):147-56. doi: 10.1016/0378-3782(95)01617-c.

    PubMed 7601018

  • Bonamy AK, Martin H, Jorneskog 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. doi: 10.1111/j.1365-2796.2007.01868.x. Epub 2007 Nov 7.

    PubMed 17986202

  • 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. doi: 10.1016/j.clinthera.2005.06.018.

    PubMed 16117989

  • 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. doi: 10.1542/peds.2005-0620C.

    PubMed 16777824

  • Tutag Lehr V, Cortez J, Grever W, Cepeda E, Thomas R, Aranda JV. Randomized placebo-controlled trial of sucrose analgesia on neonatal skin blood flow and pain response during heel lance. Clin J Pain. 2015 May;31(5):451-8. doi: 10.1097/AJP.0000000000000126.

    PubMed 24918475

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sucrose 24% oral solution and sterile water in people with Procedural Pain, run by Children's Hospital of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00694174, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2008.

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Clinical Trial NCT00694174 | AzTrials