Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

Study Overview
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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.

Official Title
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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

Conditions
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Pain Measurement

Intervention / Treatment
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* Drug: Methoxyflurane
* Drug: Normal Saline


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Methoxyflurane<br> <br> |
| Placebo Comparator: B<br> | Drug: Normal Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety of Methoxyflurane |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incident Pain, Bone Marrow Biopsy