Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

NCT00524927 | Completed Phase 4 DMC

• 1 other identifier: 06/61
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Measurement

Keywords

Incident Pain; Bone Marrow Biopsy

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Determine the safety of Methoxyflurane

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Methoxyflurane

B

PLACEBO COMPARATOR

Drug: Normal Saline

Interventions

Methoxyflurane DRUG

A

Normal Saline DRUG

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Premedication with anxiolytic (e.g. midazolam, diazepam)
• Dosed with breakthrough dose of analgesic that may contribute to control of pain during the planned procedure

Sponsors & Collaborators

• Medical Developments International Limited: lead
• Australian Department of Industry, Tourism and Resources: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3002, Australia

Location

Related Publications (1)

• 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.

  PMID: 24644183 DERIVED

MeSH Terms

Interventions

Methoxyflurane; Saline Solution

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Odette Spruyt, MD

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2007
• First Posted: September 5, 2007
• Study Start: September 1, 2007
• Study Completion: November 1, 2009
• Last Updated: January 28, 2010

Record last verified: 2010-01

Locations

AU (1)