Patients Undergoing Puncture of the Bone MarrowPhase 4NCT00188227
Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
A Phase 4 study testing Midazolam (sedative), Piritramid (analgetic) and Cognitive exercises in people with Patients Undergoing Puncture of the Bone Marrow, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patients Undergoing Puncture of the Bone Marrow
- What is being tested?
- Midazolam (sedative), Piritramid (analgetic) and Cognitive exercises
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 748 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2001to Nov 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for both first or repeated punction of the bone marrow
- Age between 18 and 85 years
- Written informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik und Poliklinik I, University Clinic Carl Gustav Carus
Dresden, Saxony, 01307
About this study
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.
Read the 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.
- Being tested
- Midazolam (sedative), Piritramid (analgetic), Cognitive exercises
- Keywords
- Bone marrow puncture, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam (sedative)Drug
Piritramid (analgetic)Drug
Cognitive exercisesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2001
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Puncture of the Bone MarrowStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 748 participants
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Investigators
- Ralph Naumann, MD, Principal investigator, University Clinic "Carl Gustav Carus" Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188227
- Sponsor's protocol ID
- CGC05MK1001
- Status last verified
- Sep 2005
- First submitted
- 10 Sep 2005
- Last updated
- 20 Apr 2007
- Results posted
- No
Publications
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.
PubMed 9576164Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11. doi: 10.1007/BF01299897.
PubMed 8261822Bein 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.
PubMed 3177831Broome 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.
PubMed 9503766Campo 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.
PubMed 10741933Chau 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.
PubMed 7968337Dahlquist 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.
PubMed 7666289Dunlop 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.
PubMed 10342892Eberhart 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.
PubMed 10900497Ellis 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.
PubMed 8021541Friedman 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.
PubMed 1961137Haberer JP. [Premedication and sedation complications during ophthalmic anesthesia]. J Fr Ophtalmol. 2000 Nov;23(9):901-6. French.
PubMed 11084450Harris 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.
PubMed 8060813Hausmann 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.
PubMed 2637069Jay 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.
PubMed 7478706
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
- ClinicalTrials.gov ID
- NCT00188227
- Acronym / sponsor ID
- CGC05MK1001
- Keywords
- Bone marrow puncture, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 748 participants
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Sep 2001
- Study completion
- Nov 2003
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for both first or repeated punction of the bone marrow
- Age between 18 and 85 years
- Written informed consent
Key exclusion criteria (12 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam (sedative) | Drug | – |
| Piritramid (analgetic) | Drug | – |
| Cognitive exercises | Behavioural | – |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
- Background: PubMed 9576164Aeschbacher 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.
- Background: PubMed 8261822Alexander JA, Smith BJ. Midazolam sedation for percutaneous liver biopsy. Dig Dis Sci. 1993 Dec;38(12):2209-11. doi: 10.1007/BF01299897.
- Background: PubMed 3177831Bein 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.
- Background: PubMed 9503766Broome 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.
- Background: PubMed 10741933Campo 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.
- Background: PubMed 7968337Chau 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.
- Background: PubMed 7666289Dahlquist 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.
- Background: PubMed 10342892Dunlop 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.
- Background: PubMed 10900497Eberhart 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.
- Background: PubMed 8021541Ellis 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.
- Background: PubMed 1961137Friedman 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.
- Background: PubMed 11084450Haberer JP. [Premedication and sedation complications during ophthalmic anesthesia]. J Fr Ophtalmol. 2000 Nov;23(9):901-6. French.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Naumann, MD principal investigator
University Clinic "Carl Gustav Carus" Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam (sedative), Piritramid (analgetic) and Cognitive exercises in people with Patients Undergoing Puncture of the Bone Marrow, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pain and anxiety during and after the punction procedure. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00188227, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2007.