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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188227
First Posted: September 16, 2005
Last Update Posted: April 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität Dresden
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Aeschbacher BC, Portner M, Fluri M, Meier B, Lüscher TF. Midazolam premedication improves tolerance of transesophageal echocardiography. Am J Cardiol. 1998 Apr 15;81(8):1022-6.
Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11.
Bein T, Tremel H, Heyde G. [Midazolam in combination with piritramid versus Thalamonal in premedication in ambulatory ENT interventions in childhood]. Anasth Intensivther Notfallmed. 1988 Aug;23(4):187-90. German.
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.
Chau SW, Chen CD, Yip WH, Hsu TL, Yu KL, Chang HC, Tseng CK. [Intravenous midazolam for sedation in epidural anesthesia]. Ma Zui Xue Za Zhi. 1993 Sep;31(3):157-64. Chinese.
Dahlquist LM, Power TG, Carlson L. Physician and parent behavior during invasive pediatric cancer procedures: relationships to child behavioral distress. J Pediatr Psychol. 1995 Aug;20(4):477-90.
Dunlop TJ, Deen C, Lind S, Voyle RJ, Prichard JG. Use of combined oral narcotic and benzodiazepine for control of pain associated with bone marrow examination. South Med J. 1999 May;92(5):477-80.
Eberhart LH, Novatchkov N, Schricker T, Georgieff M, Baur CP. [Clonidine compared to midazolam for intravenous premedication for ambulatory procedures. A controlled double blind study in ASA 1 patients]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2000 Jun;35(6):388-93. German.
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.
Hausmann D, Wahl GH, Nadstawek J. [Analgosedation as an adjuvant during surgery under local anesthesia]. Dtsch Z Mund Kiefer Gesichtschir. 1989 Jul-Aug;13(4):246-8. German.
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.
Jay SM, Elliott CH, Woody PD, Siegel S. An investigation of cognitive-behavior therapy combined with oral valium for children undergoing painful medical procedures. Health Psychol. 1991;10(5):317-22.
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.
Körner 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.
Nagahama H, Okada Y, Kinouchi H, Tateda T, Aoki T, Morokawa Y. [The use of low dose midazolam for the management of spinal anesthesia]. Masui. 1997 Jun;46(6):803-8. Japanese.
Runes J, Ström C. Midazolam intravenous conscious sedation in oral surgery. A retrospective study of 372 cases. Swed Dent J. 1996;20(1-2):29-33.

ClinicalTrials.gov Identifier: NCT00188227     History of Changes
Other Study ID Numbers: CGC05MK1001
First Submitted: September 10, 2005
First Posted: September 16, 2005
Last Update Posted: April 20, 2007
Last Verified: September 2005

Keywords provided by Technische Universität Dresden:
Bone marrow puncture
Pain

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


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