This study is performed on adult patients with suspected or known hematologic disease undergoing bone marrow aspiration and biopsy. Study investigates oral transmucosal fentanyl in the treatment of pain associated with bone marrow aspiration and biopsy.
Conditions
Interventions
Trade Name: Abstral
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: FENTANYL CITRATE
CAS Number: 990-73-8
Pharmaceutical form of the placebo: Dispersible tablet
Route of administration of
Sponsors
Helsingin yliopisto
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) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - allergy to local anesthetics or fentanyl - body mass index (BMI) over 32 - unstable angina pectoris
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparing transmucosal fentanyl with placebo in the treatment of pain associated with bone marrow aspiration and biopsy.;Secondary Objective: ;Primary end point(s): Pain defined as NRS (numeral rating scale, 0-10) during different phases of the bone marrow aspiration and biopsy procedure | — |
Countries
Finland
Outcome results
None listed