A Randomised Trial of Inhaled Entonox Plus Local Anaesthesia Versus Intravenous Midazolam Plus Local Anaesthesia To Improve Pain Control During Bone Marrow Biopsy
- Conditions
- This study will involve a group of patients requiring diagnostic bone marrow aspiration and biopsy. The reasons for these will include haematological abnormalities of the blood count , which may be caused by Leukaemia, lymphoma other related disorders.
- Registration Number
- EUCTR2005-002782-37-GB
- Lead Sponsor
- Heart of England NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
1. Patients requiring a bone marrow biopsy or trephine for the purposes of diagnosis or assessment of treatment response.
2. Sedation prefferred for the procedure.
3. Aged greater that 18 years.
4. Able to give written informed consent.
5. Fully conscious without confusion
6. Able to understand the procedure and co-operate with Entonox inhalation
7. No major psychiatric disorder
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Patients who decline sedation.
2. Patients with:-
- Chronic obstructive pulmonary disease
- Myasthenia gravis
- Pneumothorax
- Recent head injury
- Middle ear injury
3. Pregnant, breast feeding
4. History of recent diving
5. Patients unable to written informed consent
6. Known allergy to midazolam
7. Known allergy to Entonox
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method