Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001597
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Pain Measurement in Healthy Volunteers
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pain Measurement in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will attempt to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in patients
Normal healthy volunteers and dental patients undergoing third molar extraction may be eligible for this study Participants will undergo the following procedures
Volunteers Volunteers will participate in two 90-minute sessions in which they will receive and rate four heat stimuli per minute applied to the skin for a maximum of 36 minutes The heat stimuli range from 37 DegreeC to 51 DegreeC 99 Degree F to 124 Degree F and last 2 to 3 seconds A drug commonly used in dental treatments may be administered during the second session This will be either a maximum of 015 mg fentanyl a short-acting narcotic pain killer or a maximum of 5 mg saline an inactive substance placebo
Dental patients Dental patients will participate in two 60-minute sessions The first session will be on the day before the third molar extraction and the second session will be immediately before the dental procedure The heat stimulus procedure will be identical to that described above for normal healthy volunteers
Normal healthy volunteers and dental patients undergoing third molar extraction may be eligible for this study Participants will undergo the following procedures
Volunteers Volunteers will participate in two 90-minute sessions in which they will receive and rate four heat stimuli per minute applied to the skin for a maximum of 36 minutes The heat stimuli range from 37 DegreeC to 51 DegreeC 99 Degree F to 124 Degree F and last 2 to 3 seconds A drug commonly used in dental treatments may be administered during the second session This will be either a maximum of 015 mg fentanyl a short-acting narcotic pain killer or a maximum of 5 mg saline an inactive substance placebo
Dental patients Dental patients will participate in two 60-minute sessions The first session will be on the day before the third molar extraction and the second session will be immediately before the dental procedure The heat stimulus procedure will be identical to that described above for normal healthy volunteers
Detailed Description:
Mismanaged pain is still a major medical problem Many pain syndromes have no effective treatment and many are managed poorly Basic and applied research on pain treatment is hampered by the unobservable nature of pain sensation and the lack of validated measures of this perception
The purpose of this protocol is to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in clinical populations Normal volunteers rate experimentally-evoked pain sensations before and after double-blind administration of the opioid fentanyl or saline placebo Patients rate experimentally-evoked pain sensations without any drug administration
The purpose of this protocol is to develop and validate improved subjective measures of pain sensation and use these measures to evaluate pain sensitivity in clinical populations Normal volunteers rate experimentally-evoked pain sensations before and after double-blind administration of the opioid fentanyl or saline placebo Patients rate experimentally-evoked pain sensations without any drug administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-D-0104 | None | None | None |