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The pain relieving effect of nitrous oxide during bone marrow aspiration and biopsy - a placebo-controlled and randomized trial

Phase 1
Conditions
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.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2012-004285-18-FI
Lead Sponsor
Helsingin yliopisto
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
70
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

-allergy to lidocaine
-body mass index over 32 kg/m2
-unstable angina pectoris
-pregnancy
-emphysema/COPD
-dementia/Alzheimer's disease

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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