PainPhase 3NCT00219713
Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.
A Phase 3 study testing nitrous oxide and oxygen in people with Pain, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pain
- What is being tested?
- nitrous oxide and oxygen
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2000to Dec 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Placebo-Controlled Double Blind Trial Comparing Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture in Combination With Local Local 1% Xylocaine Anesthetic Versus Placebo in Order to Evaluate Pain Intensity During Bone Marrow Biopsy.
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
Read the detailed description
The efficacy of an inhaled equimolar mixture of nitrous oxide and oxygen to prevent procedural pain during lumbar puncture in children has been demonstrated. In adults the use of an inhaled equimolar mixture could prevent pain.
Although nitrous oxide was initially considered innocuous, evidence began to be gathered later that it had potentially side effect. It has been demonstrated that nitrous oxide inactivates the vitamin B12-dependent enzyme methionine synthetase and impairs DNA synthesis in bone marrow cells.
Therefore this prospective, multicenter randomized placebo controlled, double-blind trial was design to determine whether an inhaled equimolar mixture of nitrous oxide and oxygen would significantly reduce pain during bone marrow biopsy with aspiration. In addition we performed a careful cytological examination of bone marrow samples in order to evaluate the quality of the picture sample.
- Conditions
- Pain
- Being tested
- nitrous oxide and oxygen
- Keywords
- Nitrous oxide and oxygen, Pain, Bone marrow biopsy, Bone marrow aspiration
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrous oxide and oxygenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce pain during bone marrow biopsy with aspiration.
Secondary outcomes (2)
Tolerability
Evaluation of the quality of the picture sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2000
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 280 participants
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Air Liquide Santé International
- Investigators
- François GUILHOT, MD, Study chair, Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219713
- Sponsor's protocol ID
- 991300
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Double Blind Trial Comparing Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture in Combination With Local Local 1% Xylocaine Anesthetic Versus Placebo in Order to Evaluate Pain Intensity During Bone Marrow Biopsy.
- ClinicalTrials.gov ID
- NCT00219713
- Acronym / sponsor ID
- 991300
- Conditions
- Pain
- Keywords
- Nitrous oxide and oxygen, Pain, Bone marrow biopsy, Bone marrow aspiration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 280 participants
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Air Liquide Santé International
- Study start
- Mar 2000
- Study completion
- Dec 2004
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The efficacy of an inhaled equimolar mixture of nitrous oxide and oxygen to prevent procedural pain during lumbar puncture in children has been demonstrated. In adults the use of an inhaled equimolar mixture could prevent pain.
Although nitrous oxide was initially considered innocuous, evidence began to be gathered later that it had potentially side effect. It has been demonstrated that nitrous oxide inactivates the vitamin B12-dependent enzyme methionine synthetase and impairs DNA synthesis in bone marrow cells.
Therefore this prospective, multicenter randomized placebo controlled, double-blind trial was design to determine whether an inhaled equimolar mixture of nitrous oxide and oxygen would significantly reduce pain during bone marrow biopsy with aspiration. In addition we performed a careful cytological examination of bone marrow samples in order to evaluate the quality of the picture sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitrous oxide and oxygen | Drug | – |
Primary outcome
Reduce pain during bone marrow biopsy with aspiration.
2 secondary outcomes
Tolerability
Evaluation of the quality of the picture sample
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François GUILHOT, MD study chair
Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nitrous oxide and oxygen in people with Pain, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce pain during bone marrow biopsy with aspiration.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2005.