Bone Marrow Aspiration Pain Study

NCT01524523 | Withdrawn

• 2 other identifiers: 12000112-CC-0001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Pain; Gene Expression; Nitric Oxide

Keywords

Gene Expression; Acute Pain; Nitric Oxide; Pain; Bone Marrow

Outcome Measures

Primary Outcomes (1)

• Differences over time between whole blood gene expression in the peripheral blood of healthy subjects undergoing an acute pain stimulus.

Secondary Outcomes (2)

• Quantification and differences in laboratory correlates (particularly plasma nitrite, nitrosated proteins, and cyclic GMP) in health subjects pre- and post-BMA.

• Quantification of pain sensory perception in healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Related Publications (3)

• 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.

  PMID: 9057664 BACKGROUND

• The labrets of the northern "Esquimaux" (1826). Alaska Med. 1991 Apr-Jun;33(2):93. No abstract available.

  PMID: 1892235 BACKGROUND

• McKerrell TD, Cohen HW, Billett HH. The older sickle cell patient. Am J Hematol. 2004 Jun;76(2):101-6. doi: 10.1002/ajh.20075.

  PMID: 15164373 BACKGROUND

MeSH Terms

Conditions

Acute Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wendy B Smith, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 2, 2012
• Study Start: December 2, 2011
• Study Completion: June 27, 2013
• Last Updated: July 2, 2017

Record last verified: 2013-06-27