- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00219713
Evaluation of Pain Intensity During Bone Marrow Biopsy Performed With Inhalation of Pre-Mixed 50 Per Cent Nitrous Oxide and Oxygen Mixture.
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
Study Overview
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 Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Poitiers, France, 86021
- University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Reduce pain during bone marrow biopsy with aspiration.
|
Secondary Outcome Measures
Outcome Measure |
---|
Tolerability
|
Evaluation of the quality of the picture sample
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: François GUILHOT, MD, Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 991300
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on nitrous oxide and oxygen
-
Beth Israel Deaconess Medical CenterBoston Children's HospitalCompletedLower Urinary Tract SymptomsUnited States
-
The Cleveland ClinicCompletedComplex Regional Pain SyndromeUnited States
-
Beth Israel Deaconess Medical CenterBrigham and Women's HospitalCompletedPain | Benign Prostatic Hyperplasia | Prostate Cancer | Prostate Adenocarcinoma | Anxiety and Fear | Malignancy | Prostate DiseaseUnited States
-
Nabeel AliCompletedRetinopathy of PrematurityCanada
-
Air Liquide Santé InternationalAMS Advanced Medical Services GmbHCompleted
-
Washington University School of MedicineFoundation for Anesthesia Education and ResearchCompletedCardiovascular AbnormalitiesUnited States
-
The First Affiliated Hospital with Nanjing Medical...CompletedLung Cancer | Pulmonary Nodule, Solitary | Pulmonary Nodule, MultipleChina
-
University of ChicagoNational Institute on Drug Abuse (NIDA)CompletedSubstance-Related Disorders | Opioid-Related DisordersUnited States
-
Francisco GroppoFaculty Sao Leopoldo Mandic Campinas; pontifical catholic university - Rio...Completed
-
Air Liquide Santé InternationalWithdrawn