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Completed

NCT Number: NCT00188227

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus

Dresden, Saxony, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midazolam (sedative)

Drug

Piritramid (analgetic)

Drug

Cognitive Exercises

Behavioral

Primary outcomes

  1. Reduction of pain and anxiety during and after the punction procedure

  2. 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

  1. Duration of the effective pain reduction in each of the investigated groups

  2. Assessment of the quality of life in the period immediately after the bone marrow puncture

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Important dates

Study start
2001
Study completion
2003
First posted
Sep 16, 2005
Registry last updated
Apr 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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