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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Multimodal Approach to the Ontogenesis of Nociception in Very Preterm and Term Infants

NCT05404594

Procedural Pain Pre-Term Venipuncture

UNKNOWN NA

Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes

NCT03252327

Preterm Infants Pain

COMPLETED NA

Laser Acupuncture for Pain Prevention in Neonates

NCT00528125

Pain

COMPLETED NA

Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents

NCT05816174

Chronic Post Operative Pain

RECRUITING

Epidemiology of Pain in the Delivery Room

NCT03055039

New Born Child Pain

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Somatosensory Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NICU full-term early pain group

Thermal stimulation

Intervention Type DEVICE

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.

NICU premature early pain group

Thermal stimulation

Intervention Type DEVICE

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.

NICU premature control group

Thermal stimulation

Intervention Type DEVICE

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.

Soroka- full-term control group

Thermal stimulation

Intervention Type DEVICE

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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