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Reducing pain and discomfort during and after bone marrow aspiration


- candidate number25431
- NTR NumberNTR6138
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-okt-2016
- Secondary IDsNL58525.048.16 Protocolnummer
- Public TitleReducing pain and discomfort during and after bone marrow aspiration
- Scientific TitleReducing pain and discomfort during and after bone marrow aspiration
- ACRONYMREPADI
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedBone marrow cells, Pain, Anxiety
- Inclusion criteria1. 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 criteria1. Known allergy for any of the study medicines
2. Pregnancy
3. In hospital patients
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 14-dec-2016
- planned closingdate1-dec-2017
- Target number of participants48
- InterventionsGroup 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
- 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
- TimepointsVAS for pain directly after procedure, VAS for anxiety, fear for a next bone marrow biopsy, 2 weeks after the procedure
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Karin Leber
- CONTACT for SCIENTIFIC QUERIES J.M.M.B. Otten
- Sponsor/Initiator MC Slotervaart
- Funding
(Source(s) of Monetary or Material Support)
Stichting Klinisch Wetenschappelijk Onderzoek Slotervaartziekenhuis
- Publications
- Brief summaryA 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.
- Main changes (audit trail)
- RECORD19-okt-2016 - 22-jan-2017


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