Acute Pain Clinical Trial
Official title:
Biochemical and Genetic Mechanisms of Acute Clinical Pain During Bone Marrow Aspiration
Verified date | June 27, 2013 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- Many people feel pain during and after bone marrow aspiration (collection). Studies suggest
that pain may be related to different kinds of inflammation, or the presence of nitric oxide
(a normally occurring gas) in the body. Researchers want to study nitric oxide levels in the
blood and breath before and after bone marrow collection. They will look at how these levels
relate to feelings of pain.
Objectives:
- To better understand pain related to having a bone marrow collection.
Eligibility:
- Individuals at least 18 years of age who are enrolled in a study that requires bone marrow
collection.
Design:
- Participants will be screened with a physical exam, medical history, and blood sample.
- Participants will provide study blood and breath samples to check nitric oxide levels.
Participants will also have a test to measure skin sensitivity to heat and touch.
- During the collection, participants will keep track of their pain levels.
- After the collection, participants will keep track of any pain medications they take.
They will also record if and when they eat any foods that contain nitrates for about 24
hours.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 27, 2013 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA FOR SUBJECTS: All subjects enrolled in the parent protocol are eligible for enrollment in this study provided they have met all the inclusion criteria in the parent protocol and if they meet all of the following criteria: - Age greater than or equal to 18 years old. - No chronic medication use that in the judgment of the investigators could confound the study or biomarker measurements. - Can speak and understand English to complete assessments and scales EXCLUSION CRITERIA FOR ALL STUDY PARTICIPANTS: Study participants will be excluded from the study if he/she has one or more of the following: - Inability to provide informed consent. - Drug or alcohol dependence/abuse within the past 5 years - Cigarette smoking or the use of any tobacco products within two years - Use of tranquilizers, steroids, and non-steroidal anti-inflammatory agents three or more times per week. - Clinically significant medical condition that will confound the analysis of factors associated with pain, such as: - Chronic inflammatory disease (i.e. rheumatoid arthritis, systemic lupus erythematosus, cirrhosis) - Chronic pain condition - Diabetes mellitus - Known malignancies |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
McKerrell TD, Cohen HW, Billett HH. The older sickle cell patient. Am J Hematol. 2004 Jun;76(2):101-6. — View Citation
The labrets of the northern "Esquimaux" (1826). Alaska Med. 1991 Apr-Jun;33(2):93. — View Citation
Vichinsky EP, Styles LA, Colangelo LH, Wright EC, Castro O, Nickerson B. Acute chest syndrome in sickle cell disease: clinical presentation and course. Cooperative Study of Sickle Cell Disease. Blood. 1997 Mar 1;89(5):1787-92. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences over time between whole blood gene expression in the peripheral blood of healthy subjects undergoing an acute pain stimulus. | |||
Secondary | Quantification and differences in laboratory correlates (particularly plasma nitrite, nitrosated proteins, and cyclic GMP) in health subjects pre- and post-BMA. | |||
Secondary | Quantification of pain sensory perception in healthy subjects |
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