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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00503100

Enrollment

Registered

2007-07-18

Start date

2007-08-31

Completion date

2014-01-31

Last updated

2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatosensory Disorders

Keywords

Pain, Preterm-Born Adolescents

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.

Interventions

DEVICEThermal 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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).	During the test

Secondary

Measure	Time frame
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026