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Somatosensory Evoked Potentials and Pain Thresholds in Term and Preterm-Born Adolescents After Early Exposure to Pain; a Quantitative Study

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ClinicalTrials.gov Identifier: NCT00503100
Recruitment Status : Terminated (Difficulties in recruiting)
First Posted : July 18, 2007
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Pesach Shvartzman, Soroka University Medical Center

Brief Summary:

Background: Several studies have indicated that infants who had undergone postnatal painful procedures appear to be hypersensitive to pain, with a lower threshold to tactile stimulations later on life.

Objective: To study the effect of early exposure to pain on cerebral somatosensory evoked potential (SEP) response to thermal stimulation (550C), in preterm and full term born adolescents (15-18 years old), who have undergone painful procedures during their neonatal period. As well as to study the effect of early exposure to thermal and tactile sensory thresholds and pain thresholds to thermal and tactile stimuli, by using the TSA and von Frey hairs.

Design: Case-control study.

Participants: Four groups of 20 adolescents (aged 15-18 years), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.

Main Outcome Measures: Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.


Condition or disease Intervention/treatment
Somatosensory Disorders Device: Thermal stimulation

Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : August 2007
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Group/Cohort Intervention/treatment
NICU full-term early pain group Device: Thermal stimulation
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.

NICU premature early pain group Device: Thermal stimulation
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.

NICU premature control group Device: Thermal stimulation
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.

Soroka- full-term control group Device: Thermal stimulation
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.




Primary Outcome Measures :
  1. Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). [ Time Frame: During the test ]

Secondary Outcome Measures :
  1. Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). [ Time Frame: At time of the test ]
  2. Pain threshold to tactile stimulation will be measured by using Von-Frey hairs [ Time Frame: At time of the test ]


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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Four groups of 20 adolescents (aged 14 years or older), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.
Criteria

Inclusion Criteria:

For all:

  • Age 15-18
  • Appropriate weight for gestational age (AGA)
  • Informed consent signed by the parent
  • Presence of one parent during the examination

Premature groups:

  • Preterm-born (32-34 weeks of gestation)
  • Admitted to the NICU (ventilated vs. non-ventilated)

Full term groups:

  • Completed 37 weeks of gestation Pain groups (premature and full term)
  • Admitted to the NICU
  • Mechanically-ventilated during the first week of life
  • Mechanically-ventilated for at least 48 hours

Exclusion Criteria:

  • Current use of analgesia
  • A chronic illness with current medical treatment
  • Cognitive impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503100


Locations
Israel
Ben Gurion University of the Negev, Siaal research center for family medicine and primary care
Beer-Sheva, Israel, 84105
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Pesach Shvartzman, MD Ben-Gurion University of the Negev

Responsible Party: Pesach Shvartzman, Head Department of Family Medicine, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00503100     History of Changes
Other Study ID Numbers: SOR458107CTIL
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by Pesach Shvartzman, Soroka University Medical Center:
Pain
Preterm-Born Adolescents

Additional relevant MeSH terms:
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms