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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Soroka University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Pesach Shvartzman, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00503100
First received: July 17, 2007
Last updated: July 3, 2012
Last verified: July 2012
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: July 17, 2007
Last Updated: July 3, 2012
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 24, 2014