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A Phase IV, Randomized, Double Blind, Single Centre, Placebo Controlled Study to Assess the Safety and Efficacy of Methoxyflurane [Penthrox] for the Treatment of Incident Pain in Participants Undergoing a Bone Marrow Biopsy Procedure


Phase 4
18 Years
N/A
Not Enrolling
Both
Pain Measurement

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Trial Information

A Phase IV, Randomized, Double Blind, Single Centre, Placebo Controlled Study to Assess the Safety and Efficacy of Methoxyflurane [Penthrox] for the Treatment of Incident Pain in Participants Undergoing a Bone Marrow Biopsy Procedure


Inclusion Criteria:



- Adult participants (18 years of age or older)

- Able to give written informed consent

- Anticipated episode(s) of incident pain related to planned BMB lasting no more than
30 minutes on average

- Anticipated life expectancy of at least 1 month

Pre-Exclusion Criteria:

- Subjects with a clinical condition that may, in the opinion of the investigator,
impact on the subject's ability to participate in the study, or on the study results

- Participants who have had IV sedation/opioid on previous BMB and who wish to receive
IV sedation/opioid on this occasion or who in the opinion of the BMB operator would
be advised to receive IV sedation/opioid on this occasion

- Concomitant use of other investigational agents

- Concomitant use of nephrotoxic agents such as gentamicin

- Uncontrolled INR (>4)

- Personal or familial hypersensitivity to fluorinated anaesthetics

- Personal or familial malignant hyperthermia

- Respiratory rate of less than 10 per minute

- Has previously received methoxyflurane

- Known pre-existing renal or hepatic impairment

- Compromised Renal Function (creatinine ≥ 1.5 x ULNR)

- Compromised Liver Function (bilirubin ≥ 2.5 x ULNR)

Exclusion Criteria:

- Premedication with anxiolytic (e.g. midazolam, diazepam)

- Dosed with breakthrough dose of analgesic that may contribute to control of pain
during the planned procedure

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy

Principal Investigator

Odette Spruyt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

06/61

NCT ID:

NCT00524927

Start Date:

September 2007

Completion Date:

November 2009

Related Keywords:

  • Pain Measurement
  • Incident Pain
  • Bone Marrow Biopsy

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