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

Tracking Information

First Received Date ^ICMJE

July 17, 2007

Last Updated Date

April 1, 2008

Start Date ^ICMJE

August 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). [ Time Frame: During the test ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00503100 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Somatosensory Disorders

Intervention ^ICMJE

Device: Thermal stimulation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pesach Shvartzman, MD	972-8-6477429	spesah@bgu.ac.il
Contact: Oren Tamir, MD	972-8-6477433	orentamir@gmail.com

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00503100

Responsible Party

Prof Pesach Shvartzman, Ben-Gurion University of the Negev

Study ID Numbers ^ICMJE

SOR458107CTIL

Study Sponsor ^ICMJE

Soroka University Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Pesach Shvartzman, MD

Ben-Gurion University of the Negev

Information Provided By

Soroka University Medical Center

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP