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.
Conditions
Interventions
Trade Name: Entonox 50% Oxygen/Nitrous Oxide
Product Name: Entonox
Product Code: Entonox
Pharmaceutical Form: Inhalation gas
Trade Name
Sponsors
Heart of England NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Based on the results of this study we would like to optimise our current management of bone marrow biopsy pain relief in the Haematology Department at Heartlands Hospital. ; Main Objective: Aim of Study This study compares the use of inhaled 50:50 nitrous oxide and oxygen (Entonox) with titrated intravenous midazolam in patients undergoing bone marrow biopsy. All patients will receive local anaesthesia as standard practice. Primary endpoints To determine which agent 1. To identify whether Entonox is equivalent to midazolam in delivering adequate pain control for bone marrow biopsy 2. Results in a more pleasant experience for patients Based on the result we would like to optimise our current management in the Haematology Department at Birmingham Heeartlands Hospital ; Secondary Objective: Secondary Endpoints To determine which agent 1. Results in fewer side effects Nausea Hallucinations Agitation Requirement for reversal of sedation 2. Requires least occupancy of Day Unit beds and nursing time | — |
Countries
United Kingdom
Outcome results
None listed