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Penthrox vs nitrous oxide for painful emergency medicine procedures

A randomised controlled trial comparing Penthrox (methoxyflurane) with nitrous oxide for analgesia during painful emergency medicine procedures in patients aged eight years and over

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001117505
Acronym
N/A
Enrollment
198
Registered
2024-09-17
Start date
2024-09-18
Completion date
2026-09-09
Last updated
2024-09-23

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

Conditions

None listed

Brief summary

Timely provision of analgesia in the emergency department is often challenging, especially during periods of high patient demand. This has been exacerbated by ongoing staff shortages since the COVID-19 pandemic. Although several analgesic options already exist in the emergency department setting, not all clinical scenarios are well catered for. In particular, patients who are required to undergo a painful procedure in the emergency department, such as suturing, wound debridement or reduction of a fracture, often have to wait for a considerable length of time due to lack of an available treatment space with a nitrous oxide wall outlet, inadequate staffing to provide a second clinician or inadequate fasting. Penthrox provides an alternative that may alleviate some of these issues, allowing for more timely administration than nitrous oxide and subsequently a shorter length of stay. Although a number of studies have been published comparing Penthrox with placebo, there are no good quality head-to-head studies that directly compare Penthrox with nitrous oxide.

Interventions

This trial will examine the effectiveness of Penthrox (methoxyflurane; intervention) versus nitrous oxide (comparator) in emergency department patients undergoing painful procedures. Participants randomised to the Penthrox arm will be asked to inhale and exhale into the mouthpiece of a 3mL Penthrox device for 6–8 breaths, beginning inhalation thirty seconds before commencement of the procedure, after which they can continue to inhale continuously or intermittently as required for the duration of

This trial will examine the effectiveness of Penthrox (methoxyflurane; intervention) versus nitrous oxide (comparator) in emergency department patients undergoing painful procedures. Participants randomised to the Penthrox arm will be asked to inhale and exhale into the mouthpiece of a 3mL Penthrox device for 6–8 breaths, beginning inhalation thirty seconds before commencement of the procedure, after which they can continue to inhale continuously or intermittently as required for the duration of the procedure while under observation by the clinician researcher. A second 3mL bottle may be used for continued analgesia if deemed necessary by the clinician researcher.

Sponsors

Eastern Health
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
8 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Age of eight years or older • Attending Box Hill Hospital’s Emergency Department Fast Track area • Requiring a potentially painful procedure that would normally involve the use of nitrous oxide • Trained clinician researcher available to enrol patient, administer either medication, and instruct/assist participants with self-administration of Penthrox where necessary.

Exclusion criteria

• Inability to self-administer Penthrox • Inability to give verbal or written consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026