Clinical trial NCT00188227: Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
Official title: Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients Undergoing Puncture of the Bone Marrow
Keywords: Bone marrow puncture
Pain
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Reduction of pain and anxiety during and after the punction procedure
measure: Comparison of the efficacy of the three investigated methods to the placebo group, as well as to the group not receiving any pretreatment at all.
Secondary outcomes:
measure: Duration of the effective pain reduction in each of the investigated groups
measure: Assessment of the quality of life in the period immediately after the bone marrow puncture
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus
state: Sachsen
Study officials:
affiliation: University Clinic "Carl Gustav Carus" Dresden
name: Ralph Naumann, MD
role: PRINCIPAL_INVESTIGATOR
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