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

NCT00188227 | Completed Phase 4

• 1 other identifier: CGC05MK1001
• Study Type: interventional
• Target: 748
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Puncture of the Bone Marrow

Keywords

Bone marrow puncture; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Interventions

Midazolam (sedative) DRUG

Piritramid (analgetic) DRUG

Cognitive exercises BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for both first or repeated punction of the bone marrow
• Age between 18 and 85 years
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

Related Publications (25)

• Aeschbacher BC, Portner M, Fluri M, Meier B, Luscher TF. Midazolam premedication improves tolerance of transesophageal echocardiography. Am J Cardiol. 1998 Apr 15;81(8):1022-6. doi: 10.1016/s0002-9149(98)00083-6.

  PMID: 9576164 BACKGROUND

• Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11. doi: 10.1007/BF01299897.

  PMID: 8261822 BACKGROUND

• 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.

  PMID: 3177831 BACKGROUND

• 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. doi: 10.1016/S0882-5963(98)80068-7.

  PMID: 9503766 BACKGROUND

• 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. doi: 10.1097/00042737-200012020-00009.

  PMID: 10741933 BACKGROUND

• 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.

  PMID: 7968337 BACKGROUND

• 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. doi: 10.1093/jpepsy/20.4.477.

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• 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. doi: 10.1097/00007611-199905000-00005.

  PMID: 10342892 BACKGROUND

• 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. doi: 10.1055/s-2000-12055. German.

  PMID: 10900497 BACKGROUND

• 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. doi: 10.1016/0885-3924(94)90162-7.

  PMID: 8021541 BACKGROUND

• 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. doi: 10.1002/mpo.2950190610.

  PMID: 1961137 BACKGROUND

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

  PMID: 11084450 BACKGROUND

• 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. doi: 10.3109/08880019409141672.

  PMID: 8060813 BACKGROUND

• 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.

  PMID: 2637069 BACKGROUND

• 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. doi: 10.1016/0304-3959(94)00216-2.

  PMID: 7478706 BACKGROUND

• 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. doi: 10.1037//0022-006x.58.6.799.

  PMID: 2292629 BACKGROUND

• 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. doi: 10.1037//0278-6133.10.5.317.

  PMID: 1935866 BACKGROUND

• 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.

  PMID: 8189620 BACKGROUND

• 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.

  PMID: 10721198 BACKGROUND

• 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. doi: 10.1080/00207149908410025.

  PMID: 10208073 BACKGROUND

• 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.

  PMID: 9054704 BACKGROUND

• 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. doi: 10.1111/j.1399-6576.1986.tb02440.x.

  PMID: 3766098 BACKGROUND

• Milligan DW, Howard MR, Judd A. Premedication with lorazepam before bone marrow biopsy. J Clin Pathol. 1987 Jun;40(6):696-8. doi: 10.1136/jcp.40.6.696.

  PMID: 3611398 BACKGROUND

• 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.

  PMID: 9223885 BACKGROUND

• Runes J, Strom C. Midazolam intravenous conscious sedation in oral surgery. A retrospective study of 372 cases. Swed Dent J. 1996;20(1-2):29-33.

  PMID: 8738906 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Midazolam; Hypnotics and Sedatives; Pirinitramide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Isonipecotic Acids; Acids, Heterocyclic; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ralph Naumann, MD

  University Clinic "Carl Gustav Carus" Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 16, 2005
• Study Start: September 1, 2001
• Study Completion: November 1, 2003
• Last Updated: April 20, 2007

Record last verified: 2005-09

Locations

DE (1)