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

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:

MedlinePlus related topics: Anxiety

Drug Information available for: Midazolam hydrochloride

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

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

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

Dresden University of Technology

Investigators

Principal Investigator:

Ralph Naumann, MD

University Clinic "Carl Gustav Carus" Dresden

More Information

Publications:

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Broome ME, Rehwaldt M, Fogg L. Relationships between cognitive behavioral techniques, temperament, observed distress, and pain reports in children and adolescents during lumbar puncture. J Pediatr Nurs. 1998 Feb;13(1):48-54.

Campo R, Brullet E, Montserrat A, Calvet X, Donoso L, Bordas JM. Efficacy of low and standard midazolam doses for gastroscopy. A randomized, double-blind study. Eur J Gastroenterol Hepatol. 2000 Feb;12(2):187-90.

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Ellis JA, Spanos NP. Cognitive-behavioral interventions for children's distress during bone marrow aspirations and lumbar punctures: a critical review. J Pain Symptom Manage. 1994 Feb;9(2):96-108. Review.

Friedman AG, Mulhern RK, Fairclough D, Ward PM, Baker D, Mirro J, Rivera GK. Midazolam premedication for pediatric bone marrow aspiration and lumbar puncture. Med Pediatr Oncol. 1991;19(6):499-504.

Haberer JP. [Premedication and sedation complications during ophthalmic anesthesia] J Fr Ophtalmol. 2000 Nov;23(9):901-6. French.

Harris CV, Bradlyn AS, Ritchey AK, Olsen BR, Pisaruk HI. Individual differences in pediatric cancer patients' reactions to invasive medical procedures: a repeated measures analysis. Pediatr Hematol Oncol. 1994 May-Jun;11(3):293-9.

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Jay S, Elliott CH, Fitzgibbons I, Woody P, Siegel S. A comparative study of cognitive behavior therapy versus general anesthesia for painful medical procedures in children. Pain. 1995 Jul;62(1):3-9.

Jay SM, Elliott CH. A stress inoculation program for parents whose children are undergoing painful medical procedures. J Consult Clin Psychol. 1990 Dec;58(6):799-804.

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Kasaba T. [The effects of small dose midazolam in patients to reduce the uncomfortable feeling during epidural block procedure] Masui. 1994 Apr;43(4):547-50. Japanese.

Korner I, Scherhag A, Preussner PR. [Analgosedation (managed anesthesia care--MAC) with propofol and piritramide for controlled cyclophotocoagulation of the eye] Anaesthesiol Reanim. 2000;25(1):22-5. German.

Liossi C, Hatira P. Clinical hypnosis versus cognitive behavioral training for pain management with pediatric cancer patients undergoing bone marrow aspirations. Int J Clin Exp Hypn. 1999 Apr;47(2):104-16.

Mainwaring CJ, Wong C, Lush RJ, Smith JG, Singer CR. The role of midazolam-induced sedation in bone marrow aspiration/trephine biopsies. Clin Lab Haematol. 1996 Dec;18(4):285-8.

Maunuksela EL, Rajantie J, Siimes MA. Flunitrazepam-fentanyl-induced sedation and analgesia for bone marrow aspiration and needle biopsy in children. Acta Anaesthesiol Scand. 1986 Jul;30(5):409-11.

Milligan DW, Howard MR, Judd A. Premedication with lorazepam before bone marrow biopsy. J Clin Pathol. 1987 Jun;40(6):696-8.

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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 Dresden University of Technology:

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 May 23, 2013