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Somatosensory Evoked Potentials and Pain Thresholds in Term and Preterm-Born Adolescents After Early Exposure to Pain; a Quantitative Study
This study is currently recruiting participants.
Verified by Soroka University Medical Center, March 2008
Sponsored by: Soroka University Medical Center
Information provided by: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00503100
  Purpose

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 Intervention
Somatosensory Disorders
 Device: Thermal stimulation

U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). [ Time Frame: During the test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Pain threshold to tactile stimulation will be measured by using Von-Frey hairs [ Time Frame: At time of the test ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 80
Study Start Date: August 2007
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503100

Contacts
Contact: Pesach Shvartzman, MD 972-8-6477429 spesah@bgu.ac.il
Contact: Oren Tamir, MD 972-8-6477433 orentamir@gmail.com

Locations
Israel
Ben Gurion University of the Negev, Siaal research center for family medicine and primary care Recruiting
Beer-Sheva, Israel, 84105
Contact: Oren Tamir, MD     972-8-6477433     orentamir@gmail.com    
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Pesach Shvartzman, MD Ben-Gurion University of the Negev
  More Information

Responsible Party: Ben-Gurion University of the Negev ( Prof Pesach Shvartzman )
Study ID Numbers: SOR458107CTIL
Study First Received: July 17, 2007
Last Updated: April 1, 2008
ClinicalTrials.gov Identifier: NCT00503100  
Health Authority: Israel: Ministry of Health

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

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Somatosensory Disorders
Neurologic Manifestations
Pain

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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