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Clinical Trials/NCT00503100
NCT00503100
Terminated
Not Applicable

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

Soroka University Medical Center1 site in 1 country10 target enrollmentAugust 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Somatosensory Disorders
Sponsor
Soroka University Medical Center
Enrollment
10
Locations
1
Primary Endpoint
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
January 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pesach Shvartzman

Head Department of Family Medicine

Soroka University Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).

Time Frame: During the test

Secondary Outcomes

  • 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)
  • Pain threshold to tactile stimulation will be measured by using Von-Frey hairs(At time of the test)

Study Sites (1)

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