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ID
Source
Brief title
Health condition
Bone marrow aspiration and biopsy
Pain
Anxiety
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Visual Analogue Scale (VAS) for pain, directly after the procedure
- Visual Analogue Scale (VAS) for anxiety, fear for a next bone marrow aspiration and biopsy measured two weeks after the procedure
Secondary outcome
- Fear of Pain Questionnaire-III
- VAS for pain and anxiety at other moments than described at the main study parameters
- VAS for discomfort
- Possibility to follow instructions during the procedure
Background summary
A bone marrow aspiration and biopsy (BMAB) is a diagnostic medical intervention which is
generally conducted with only local anaesthesia. Most of the patients experience discomfort
and pain during this procedure and do not favour a next BMAB. No strict guideline exists on
the use of pain and anxiety medication before a BMAB. In our hospital setting two different
premedication schemes are used for pain and anxiety reduction. This study will investigate
the different schemes of premedication on the pain during and after a BMAB and for the fear
for a possible next BMAB. The main objective is to investigate which premedication scheme
reduces best the pain during and after a BMAB and which premedication scheme reduces
best the fear for a possible next BMAB. We will conduct a double-blind randomized
controlled study and adult patients with an indication to undergo a first bone marrow
aspiration and/or biopsy will be included. The two different premedication schemes consist of
1: lorazepam 1mg and paracetamol 1000mg both oral administration and 2: midazolam
7,5mg and morphine 10mg both oral administration. The primary study endpoints are the
Visual Analogue Scale (VAS) for pain, scored directly after the procedure and fear for a next
BMAB scored on a VAS for anxiety two weeks after the procedure. Secondary endpoints are
discomfort and patient related factors for pain experience.
Study objective
The main objective of this study is to investigate which premedication scheme reduces best the pain during and after a bone marrow aspiration and biopsy and reduces best the fear for a possible next bone marrow aspiration and biopsy.
Study design
VAS for pain directly after procedure, VAS for anxiety, fear for a next bone marrow biopsy, 2 weeks after the procedure
Intervention
Group 1: midazolam 7,5mg, oral, single dose AND morphine 10mg, oral single dose
Group 2: lorazepam 1mg, oral single dose AND paracetamol 1000mg, oral, single dose
Inclusion criteria
1. Patients with an indication to undergo a first bone marrow aspiration in MC Slotervaart
2. Age > 18 years
3. Patient is capable to give informed consent
Exclusion criteria
1. Known allergy for any of the study medicines
2. Pregnancy
3. In hospital patients
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5957 |
NTR-old | NTR6138 |
CCMO | NL58525.048.16 |
OMON | NL-OMON42943 |