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.
ID
Bron
Verkorte titel
Aandoening
Bone marrow aspiration and biopsy
Pain
Anxiety
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
-Visual Analogue Scale (VAS) for pain, directly after the procedure<br>
- Visual Analogue Scale (VAS) for anxiety, fear for a next bone marrow aspiration and biopsy measured two weeks after the procedure
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
VAS for pain directly after procedure, VAS for anxiety, fear for a next bone marrow biopsy, 2 weeks after the procedure
Onderzoeksproduct en/of interventie
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
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Known allergy for any of the study medicines
2. Pregnancy
3. In hospital patients
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiƫnten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5957 |
NTR-old | NTR6138 |
CCMO | NL58525.048.16 |
OMON | NL-OMON42943 |