Reducing pain and discomfort during and after bone marrow aspiration

Reducing pain and discomfort during and after bone marrow aspiration - REPADI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002906-38-NL

Enrollment

Registered

2016-10-12

Start date

2016-10-12

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and fear reduction for bone marrow examination

Interventions

Product Name: paracetamol Pharmaceutical Form: Tablet Product Name: lorazepam Pharmaceutical Form: Tablet Product Name: Morphine

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 29 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29

Exclusion criteria

Exclusion criteria: 1. Known allergy for any of the study medicines 2. Pregnancy 3. In hospital patients

Design outcomes

Primary

Measure	Time frame
Main Objective: Which premedication scheme reduces best the pain during and after a BMAB and reduces best the fear for a possible next BMAB.; Secondary Objective: 1. Which premedication reduces best the discomfort caused by BMAB 2. Are there any patient related factors that have influence on pain and anxiety during and after a BMAB 3. Are patients able to follow up instructions during the procedure after receiving an opiate and/or benzodiazepine as premedication ; Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: After 42 patients an interimanalysis will be carried out, this will be after approximately 12-14 months.	—

Measure

Time frame

Main Objective: Which premedication scheme reduces best the pain during and after a BMAB and reduces best the fear for a possible next BMAB.; Secondary Objective: 1. Which premedication reduces best the discomfort caused by BMAB 2. Are there any patient related factors that have influence on pain and anxiety during and after a BMAB 3. Are patients able to follow up instructions during the procedure after receiving an opiate and/or benzodiazepine as premedication ; Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: After 42 patients an interimanalysis will be carried out, this will be after approximately 12-14 months.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: After 42 patients an interimanalysis will be carried out, this will be after approximately 12-14 months. ; Secondary end point(s): 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	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: After 42 patients an interimanalysis will be carried out, this will be after approximately 12-14 months. ; Secondary end point(s): 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

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Countries

Netherlands

Contacts

Public ContactInternal Medicine Department

MC Slotervaart

00310205124591

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026