Reducing pain and discomfort during and after bone marrow aspiration

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2016
INTERVENTION: Product Name: paracetamol Pharmaceutical Form: Tablet Product Name: lorazepam Pharmaceutical Form: Tablet Product Name: Morphine Pharmaceutical Form: Tablet Trade Name: Dormicum Product Name: midazolam Pharmaceutical Form: Tablet CONDITION: Pain and fear reduction for bone marrow examination Therapeutic area: Not possible to specify PRIMARY OUTCOME: Main Objective: Which premedication scheme reduces best the pain during and after a BMAB and reduces best the fear for a possible next BMAB. 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 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 ; ; 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: 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 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. 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
Epistemonikos ID: f3ecda170e629739897b023c97a3b9390c47005f
First added on: Aug 24, 2024