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

Somatosensory Disorders Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00503100
• Other study ID #: SOR458107CTIL
• Status: Terminated
• Phase: N/A
• First received: July 17, 2007
• Last updated: May 20, 2015
• Start date: August 2007
• Est. completion date: January 2014

Study information

• Verified date: May 2015
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Somatosensory Disorders

Intervention

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.

Locations

Country	Name	City	State
Israel	Ben Gurion University of the Negev, Siaal research center for family medicine and primary care	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).		During the test	No
Secondary	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	No
Secondary	Pain threshold to tactile stimulation will be measured by using Von-Frey hairs		At time of the test	No