Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain Measurement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Methoxyflurane

Intervention Type DRUG

B

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Interventions

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Methoxyflurane

Intervention Type DRUG

Normal Saline

Intervention Type DRUG

Eligibility Criteria

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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

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)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes