Somatosensory Evoked Potentials and Pain Thresholds in Term and Preterm-Born Adolescents After Early Exposure to Pain; a Quantitative Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Current use of analgesia
- •A chronic illness with current medical treatment
- •Cognitive impairment
结局指标
主要结局
Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C).
时间窗: During the test
次要结局
- 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)
研究者
Pesach Shvartzman
Head Department of Family Medicine
Soroka University Medical Center