Status:
COMPLETED
Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
Lead Sponsor:
Technische Universität Dresden
Conditions:
Patients Undergoing Puncture of the Bone Marrow
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate and compare the effects of three different methods for reducing pain and anxiety in adult patients undergoing puncture of the bone marrow. The investigated ...
Detailed Description
The puncture of the bone marrow is a routine medical procedure which is often performed in the field of hematology/oncology. When carefully and appropriately performed, the puncture of the bone marrow...
Eligibility Criteria
Inclusion
- Patients scheduled for both first or repeated punction of the bone marrow
- Age between 18 and 85 years
- Written informed consent
Exclusion
- Contraindication for a punction of the bone marrow
- Administration of benzodiazepines or analgetic drugs prior to the bone marrow punction
- Known hypersensitivity to benzodiazepines or Piritramid
- Known contraindication to benzodiazepines (Myasthenia gravis in particular) or Piritramid (Pheochromocytoma or conditions affecting the consciousness)
- Poor general condition (ECOG Performance Status 3,4; Karnofsky Index \< 50%)
- Addictive disorders
- Administration of antidepressive drugs
- Administration of drugs that potentially depress the respiratory function
- Severe cardio-circulatory or respiratory insufficiency, sleep apnea syndrome
- Known bradycardia
- History of syncope(s) of unclear etiology
- Pregnancy or lactation
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
November 1 2003
Estimated Enrollment :
748 Patients enrolled
Trial Details
Trial ID
NCT00188227
Start Date
September 1 2001
End Date
November 1 2003
Last Update
April 20 2007
Active Locations (1)
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1
Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus
Dresden, Saxony, Germany, 01307