Clinical trial NCT00503100: Somatosensory Evoked Potentials and Pain Thresholds in Term and Preterm-Born Adolescents After Early Exposure to Pain; a Quantitative Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Somatosensory Disorders
Keywords: Pain
Preterm-Born Adolescents
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2007-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Four groups of 20 adolescents (aged 14 years or older), 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).
timeFrame: During the test
Secondary outcomes:
measure: 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).
timeFrame: At time of the test
measure: Pain threshold to tactile stimulation will be measured by using Von-Frey hairs
timeFrame: At time of the test
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Ben Gurion University of the Negev, Siaal research center for family medicine and primary care
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Pesach Shvartzman, MD
role: PRINCIPAL_INVESTIGATOR
References: