Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

Phase 4

Completed

• Conditions: Pain Measurement
• Interventions: Drug: Methoxyflurane; Drug: Normal Saline

• Registration Number: NCT00524927
• Lead Sponsor: Medical Developments International Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-02
• Study First Submitted QC: 2007-09-02
• Study First Posted: 2007-09-05
• Study Completion: 2009-11
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-27
• Last Update Posted: 2010-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Methoxyflurane	-
B	Normal Saline	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Determine the safety of Methoxyflurane

Trial Locations

Locations (1)

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia