Clinical trial NCT00524927: Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain Measurement
Keywords: Incident Pain
Bone Marrow Biopsy
Lead sponsor: Medical Developments International Limited
Sponsor class: INDUSTRY
Collaborators: name: Australian Department of Industry, Tourism and Resources
First posted: 2007-09-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to provide further supportive evidence that Methoxyflurane, a potent analgesic, administered using the Penthrox Inhaler is safe and efficacious in adult participants, specifically those who experience incident pain associated with a planned bone marrow biopsy.


Eligibility criteria: 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

Primary outcomes:
measure: Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy
Secondary outcomes:
measure: Determine the safety of Methoxyflurane
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Odette Spruyt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spruyt O, Westerman D, Milner A, Bressel M, Wein S. A randomised, double-blind, placebo-controlled study to assess the safety and efficacy of methoxyflurane for procedural pain of a bone marrow biopsy. BMJ Support Palliat Care. 2014 Dec;4(4):342-8. doi: 10.1136/bmjspcare-2013-000447. Epub 2013 Jun 7.