This study is performed on adult patients with suspected or known hematologic disease undergoing bone marrow aspiration and biopsy. Study investigates inhaled mixture of nitrous oxide and oxygen in the treatment of pain associated with bone marrow aspiration and biopsy.
Conditions
Interventions
Trade Name: Livopan
Pharmaceutical Form: Medicinal gas, compressed
Pharmaceutical form of the placebo: Medicinal gas, compressed
Route of administration of the placebo: Inhalation use
Pharmaceutical
Sponsors
Helsingin yliopisto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: adult patients with known or suspected hematological disease undergoing bone marrow aspiration and biopsy 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: -allergy to lidocaine -body mass index over 32 kg/m2 -unstable angina pectoris -pregnancy -emphysema/COPD -dementia/Alzheimer's disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparing inhaled mixture of nitrous oxide and oxygen with placebo (oxygen and air) in the tratment of pain associated with bone marrow aspiration and biopsy.;Secondary Objective: Not applicable.;Primary end point(s): Pain defined as NRS (numeral rating scale, 0-10) during different phases of the bone marrow aspiration and biopsy procedure.;Timepoint(s) of evaluation of this end point: During every phase (local anaesthetic infiltration, puncture, aspiration, biopsy and right after the procedure) of the bone marrow aspiration and biopsy procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cognitive effects of the study drug.;Timepoint(s) of evaluation of this end point: Before and after the procedure. | — |
Countries
Finland
Contacts
Public ContactPer Rosenberg
Helsingin yliopisto
Outcome results
None listed