NCT00219713

Brief Summary

Bone marrow biopsy is a painful medical procedure often performed with local anesthetic. Therefore a double-blind, randomized, controlled trial was carried out in 330 adult patients who where referred for bone marrow biopsy and aspiration. 164 were assigned to inhale an equimolar mixture of nitrous oxide and oxygen and 166 to inhale a placebo. Pain measurement used visual-analogue pain scales, which involve rating the intensity of pain on a horizontal ruler

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3 pain

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_3 pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 22, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Pain

Keywords

Nitrous oxide and oxygenPainBone marrow biopsyBone marrow aspiration

Outcome Measures

Primary Outcomes (1)

  • Reduce pain during bone marrow biopsy with aspiration.

Secondary Outcomes (2)

  • Tolerability

  • Evaluation of the quality of the picture sample

Interventions

nitrous oxide and oxygenDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older
  • with a good clinical condition (score ECOG \< 2)
  • without contra indication for the use of nitrous oxide or previous medical history of allergy to Xylocaïne.
  • Informed consent signed up.

You may not qualify if:

  • pregnancy,
  • prior exposure to nitrous oxide,
  • patients with neurological illness and those on anti depressant medications or with congestive heart failure or significant respiratory disease.
  • patients on analgesia for other medical conditions or whose with the inability to provided consent of an assessment of pain.
  • patients with platelet dysfunction or related coagulation disorders, aspirin or warfarin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Pain

Interventions

Nitrous OxideOxygen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsChalcogensElements

Study Officials

  • François GUILHOT, MD

    Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

March 1, 2000

Study Completion

December 1, 2004

Last Updated

September 22, 2005

Record last verified: 2005-09

Locations

FR(1)