Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
NCT ID: NCT00188227
Last Updated: 2007-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
748 participants
INTERVENTIONAL
2001-09-30
2003-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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Midazolam (sedative)
Piritramid (analgetic)
Cognitive exercises
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 85 years
* Written informed consent
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Technische Universität Dresden
OTHER
Principal Investigators
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Ralph Naumann, MD
Role: PRINCIPAL_INVESTIGATOR
University Clinic "Carl Gustav Carus" Dresden
Locations
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Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus
Dresden, Saxony, Germany
Countries
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References
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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.
Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11. doi: 10.1007/BF01299897.
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. doi: 10.1016/S0882-5963(98)80068-7.
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.
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. doi: 10.1093/jpepsy/20.4.477.
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.
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.
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.
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.
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. doi: 10.3109/08880019409141672.
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. doi: 10.1016/0304-3959(94)00216-2.
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.
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.
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. doi: 10.1080/00207149908410025.
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. doi: 10.1111/j.1399-6576.1986.tb02440.x.
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.
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, Strom C. Midazolam intravenous conscious sedation in oral surgery. A retrospective study of 372 cases. Swed Dent J. 1996;20(1-2):29-33.
Other Identifiers
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CGC05MK1001
Identifier Type: -
Identifier Source: org_study_id