The main objective of this study is to investigate which premedication scheme reduces best the pain during and after a BMAB and reduces best the fear for a possible next BMAB. Other objectives are the influence of the different medication schemes on…
ID
Source
Brief title
Condition
- Other condition
- Haematological and lymphoid tissue therapeutic procedures
Synonym
Health condition
Pijn en angstbeleving
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters
- Visual Analogue Scale (VAS) for pain, directly after the procedure
- Visual Analogue Scale (VAS) for anxiety, fear for a next BMAB two weeks after
procedure
Secondary outcome
Secondary study parameters/endpoints
- Fear of Pain Questionnaire-III
- VAS for pain and anxiety at other moments than described at the main study
parameters
- 5 point Likert scale, fear for a BMAB
- VAS for discomfort
- Possibility to follow instructions during the procedure
Background summary
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 pre-medication schemes are
used for pain and anxiety reduction. This study will investigate the different
schemes of pre-medication on the pain during and after a BMAB and for the fear
for a possible next BMAB.
Study objective
The main objective of this study is to investigate which premedication scheme
reduces best the pain during and after a BMAB and reduces best the fear for a
possible next BMAB. Other objectives are the influence of the different
medication schemes on discomfort and if there are other patient related factors
that have influence on pain and anxiety.
Study design
Study type and design: This study will be a double blind randomized
intervention study comparing two different premedication schemes for BMAB. We
will compare lorazepam 1mg and paracetamol 1000mg orally one hour before the
procedure with midazolam 7,5mg and morphine 10mg orally one hour before the
procedure.
Intervention
Intervention treatment:
Midazolam 7,5mg, oral, single dose + morphine 10mg, oral, single dose
- Midazolam is a benzodiazepine with anxiolytic, sedative and possible muscle
relaxant and anti-convulsive characteristics. Anterograde amnesia is also
described by the use of midazolam. Midazolam is used before and during
therapeutic and diagnostic procedures because of its sedative component. When
using midazolam the concentration and reaction is affected, therefore driving a
car is not recommended.
- Morphine is an opium alkaloid with a strong analgesic effect. Morphine is
used for severe acute and chronic pain. Morphine is commonly used as
premedication before anaesthesia and as analgesic during anaesthesia.
Concentration and reaction is affected if using morphine, therefore driving a
car is not recommended.
Control treatment:
Lorazepam 1mg, oral, single dose + paracetamol 1000mg, oral, single dose
- Lorazapam is a benzodiazepine with as main characteristic the anxiolytic
effect. Anterograde amnesia is also described by the use of lorazepam.
Lorazepam is indicated for short term treatment of anxiety and stress.
Lorazepam is also used as pre-treatment before operative procedures.
Concentration and reaction is affected after using lorazepam, therefore driving
a car is not recommended.
- Paracetamol is and acetanilide derivate with analgesic and antipyretic
effect. It is commonly used for mild to moderate pain. It a very well tolerated
drug.
Study burden and risks
Patients undergo a BMAB as normal, except for the premedication scheme which
will be given in a randomized order. Both premedication schemes under
investigation are used for many years in our hospital and have acceptable side
effects. Patients need to fill in a questionnaire on anxiety and a number of
scores on pain, discomfort and fear at four moments in time: before the
procedure, directly after the procedure, 2 hours after the procedure and 2
weeks after the procedure. No extra visits are needed.
Louwesweg 6
Amsterdam 1066EC
NL
Louwesweg 6
Amsterdam 1066EC
NL
Listed location countries
Age
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 written informed consent
Exclusion criteria
1. Known allergy for any of the study medicines
2. Pregnancy
3. In hospital patients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2016-002906-38-NL |
CCMO | NL58525.048.16 |
OMON | NL-OMON22677 |