Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

Medical Developments International Limited

Status and phase

Completed

Phase 4

Conditions

Pain Measurement

Treatments

Drug: Methoxyflurane

Drug: Normal Saline

Study type

Interventional

Funder types

Industry

Identifiers

NCT00524927

06/61

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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