Skin Conductance Fluctuations Per Sec and NRS to Monitor Pain
A Pilot Study for the PainMonitor During Standardized Painful Stimuli and no Stimuli to Calculate the Sensitivity and Specificity and Thereby the Accuracy of the Monitor
1 other identifier
observational
20
1 country
1
Brief Summary
To provide a preliminary evaluation of the correlation between Numeric rating Score (NRS) and skin conductance responses per second at rest and in response to a painful stimulus. Sensitivity and specificity will be calculated for NRS and skin conductance responses per sec to a standardized painful stimulus. Furthermore, predictors of pain will be examined.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 27, 2013
CompletedFirst Posted
Study publicly available on registry
May 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedDecember 4, 2013
December 1, 2013
5 months
May 27, 2013
December 3, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Skin conductance responses per sec and NRS before and during painful procedures
* No significant adverse events related to use of the Pain Monitor device * Increase in skin conductance responses per sec and NRS after administration of painful stimulus compared to the non-painful situations.
8 months
Study Arms (1)
Heart surgery
Pain monitoring at different time periods
Eligibility Criteria
Adult cardiac patients prior to, during, and after anesthesia for surgery. The proposed pilot study will be conducted at the Acute Clinic, Rikshospitalet - Oslo University hospital, Oslo, Norway.
You may qualify if:
- Age: Older than 18 years, patients scheduled for cardiac surgery.
- Patients admitted to the Cardiac Unit with cardiac disease.
- Patients able to verbally communicate pain level during or after the procedures.
- Pain medication following institutional standard care; only diazepam given before the painful procedure. During surgery, institutional standard care for sedation will be given.
You may not qualify if:
- Administration or anesthesia or analgesia other than diazepam prior to evaluation with the PainMonitor.
- Presence of any neurological disease affecting the peripheral nerves.
- Abuse of alcohol or illicit drugs
- History of mental retardation or any mental disease
- Severe neuropathic disease
- Use of neostigmine before event 1, 2, and 3, see events below.
- Use of atropin
- Use of regional anesthesia at the extremity where the device electrodes are placed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- University of Oslocollaborator
Study Sites (1)
Acute Clinic, Rikshospitalet - Oslo University hospital
Oslo, 0027, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan F Bugge, MD.PhD
Head of the Anesthesia Thorax department
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2013
First Posted
May 30, 2013
Study Start
May 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
December 4, 2013
Record last verified: 2013-12