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

This study has been completed.
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00188227
First received: September 10, 2005
Last updated: April 19, 2007
Last verified: September 2005
  Purpose

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.


Condition Intervention Phase
Patients Undergoing Puncture of the Bone Marrow
Drug: Midazolam (sedative)
Drug: Piritramid (analgetic)
Behavioral: Cognitive exercises
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • Reduction of pain and anxiety during and after the punction procedure
  • 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 Outcome Measures:
  • Duration of the effective pain reduction in each of the investigated groups
  • Assessment of the quality of life in the period immediately after the bone marrow puncture

Estimated Enrollment: 748
Study Start Date: September 2001
Estimated Study Completion Date: November 2003
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188227

Locations
Germany
Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus
Dresden, Sachsen, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Ralph Naumann, MD University Clinic "Carl Gustav Carus" Dresden
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00188227     History of Changes
Other Study ID Numbers: CGC05MK1001
Study First Received: September 10, 2005
Last Updated: April 19, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität Dresden:
Bone marrow puncture
Pain

Additional relevant MeSH terms:
Midazolam
Hypnotics and Sedatives
Pirinitramide
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotics

ClinicalTrials.gov processed this record on July 22, 2014