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

Sponsor
Soroka University Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00503100
Collaborator
(none)
10
Enrollment
1
Location
77
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: Thermal stimulation

Study Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Jan 1, 2014
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). [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). [At time of the test]

  2. Pain threshold to tactile stimulation will be measured by using Von-Frey hairs [At time of the test]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pesach Shvartzman, Head Department of Family Medicine, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00503100
Other Study ID Numbers:
  • SOR458107CTIL
First Posted:
Jul 18, 2007
Last Update Posted:
May 21, 2015
Last Verified:
May 1, 2015
Keywords provided by Pesach Shvartzman, Head Department of Family Medicine, Soroka University Medical Center
Pain
Preterm-Born Adolescents
Additional relevant MeSH terms:
Somatosensory Disorders

Study Results

No Results Posted as of May 21, 2015