Improving the Patient's Experience of a Bone Marrow Biopsy - An evidence based approach to service improvement.
- Conditions
- Procedural pain experienced during bone marrow biopsy
- Registration Number
- EUCTR2005-005410-21-GB
- Lead Sponsor
- Bradford Teaching Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Patients attending the haematology day case unit who are over 18 years of age requiring bone marrow biopsy and who agree to take part in the study.
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
Patients who have contraindications to Entonox or Oxygen:
Artificial, traumatic or spontaneous pneumothorax
Air embolism
Decompression sickness
Recent underwater dive
Severe bullous emphysema
Myringoplasty
Intestinal obtruction
Head injury with impaired consciousness
Intoxication
Maxillofacial injuries
Chronic obstructive pulmonary disease
Asthma
Wthin first 16 weeks of pregnancy
Patients who wish to drive or operate machinery within 12 hours of the procedure
In addition, patients who have used Entonox within the last 10 years will also be excluded. This will avoid the possibility of their being unblinded as to the treatment condition to which they have been allocated in the study.
Patients who have already participated in this trial and require further biopsies will not be eligible for re-entry into the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Is the level of pain experienced by patients undergoing a bone marrow biopsy improved by the administration of Entonox?;Secondary Objective: To assess the acceptability of Entonox as a method of pain control in this patient population.;<br> Primary end point(s): when the patient no longer self-administers gas<br> following completion of questionnaire<br>
- Secondary Outcome Measures
Name Time Method