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

Technische Universität Dresden

Status and phase

Completed

Phase 4

Conditions

Patients Undergoing Puncture of the Bone Marrow

Treatments

Drug: Piritramid (analgetic)

Behavioral: Cognitive exercises

Drug: Midazolam (sedative)

Study type

Interventional

Funder types

Other

Identifiers

NCT00188227

CGC05MK1001

Details and patient eligibility

About

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.

Full 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 has a very low rate of complications and is generally safe for the patient. However, it is an invasive and painful procedure associated with anxiety, especially in patients undergoing repeated punctures. Therefore an appropriate preparation of the patient for the puncture is essential in order to minimize the stress experienced during the procedure. In this regard, there are numbers of both pharmacological and non-pharmacological interventions in pedriatric patients aimed at reducing the punction related pain and anxiety in this patients. Nevertheless an evidence based approach for the pretreatment of the patients is yet to be established. The aim of this study is to investigate three different methods for reducing the pain and anxiety associated with the puncture of the bone marrow in adult patients. Two of the of the investigated methods involve pretreatment of the patients with pharmacological agents (sedative drug or analgetic drug), whereas the third method involves cognitive behavioural pretreatment in form of an audio material. The patients in the control group receive placebo injections.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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