Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture

• Status: Completed
• Trial end date: 2003-11-01
• Target enrollment: 0
• Participant gender: All

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 methods are: cognitive behavioural technique, administration of a sedative drug(Midazolam) and administration of an analgetic drug (Piritramid)prior to the procedure. Additionally, there are two comparison groups in which the patients receive either placebo treatment or no treatment at all.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität Dresden
• Treatments: Hypnotics and Sedatives; Midazolam; Pirinitramide

Criteria

Inclusion Criteria:

• Patients scheduled for both first or repeated punction of the bone marrow

• Age between 18 and 85 years

• Written informed consent

Exclusion Criteria:

• 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