Reducing pain and discomfort during and after bone marrow aspiratio

Phase 1

• Conditions: Pain and fear reduction for bone marrow examination; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2016-002906-38-NL
• Lead Sponsor: MC Slotervaart

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 58

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Which premedication scheme reduces best the pain during and after a BMAB and reduces best the fear for a possible next BMAB.;<br> Secondary Objective: 1.Which premedication reduces best the discomfort caused by BMAB<br><br> 2.Are there any patient related factors that have influence on pain and anxiety during and after a BMAB<br><br> 3.Are patients able to follow up instructions during the procedure after receiving an opiate and/or benzodiazepine as premedication<br><br> ;<br> Primary end point(s): Main study parameters<br> -Visual Analogue Scale (VAS) for pain, directly after the procedure<br> -Visual Analogue Scale (VAS) for anxiety, fear for a next BMAB two weeks after procedure<br> ;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 Outcome Measures

Name	Time	Method
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. ;<br> Secondary end point(s): Secondary study parameters/endpoints<br> -Fear of Pain Questionnaire-III<br> -VAS for pain and anxiety at other moments than described at the main study parameters<br> -5 point Likert scale, fear for a BMAB<br> -VAS for discomfort<br> -Possibility to follow instructions during the procedure<br>