Safety and Efficacy of Methoxyflurane for Treatment of Incident Pain

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00524927

Enrollment

110

Registered

2007-09-05

Start date

2007-09-30

Completion date

2009-11-30

Last updated

2010-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Measurement

Keywords

Incident Pain, Bone Marrow Biopsy

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.

Interventions

DRUGMethoxyflurane

DRUGNormal Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	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

Measure	Time frame
Determine the safety of Methoxyflurane	—

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026