MONITOR - MethOxyfluraNe in InTerventiOnal Radiology
Prospective double blind randomised controlled study comparing patient experience and analgesia, between methoxyflurane (Penthrox®) vs placebo for patients requiring interventional radiological procedures
South Western Sydney Local Health District Human Research Ethics Committee
322 participants
Oct 30, 2022
Interventional
Conditions
Summary
Procedures performed in interventional radiology are often quick and minimally invasive, such as portacath insertions, portacath removal and deep tissue biopsies. These procedures are most commonly performed under local anaesthetic alone, which may not always adequately control your levels of pain or anxiety, leading to suboptimal patient experiences. Occasionally, a procedure may have to be abandoned or rescheduled if it is not tolerated with local anaesthesia alone. Methoxyflurane (Penthrox) is a safe inhaled pain relief medication traditionally used in the community, ambulance and emergency department settings. It is administered via a hand-held “green whistle” that you can safely use as much as you want or need during the procedure. The device delivers the medication very quickly but limits the amount of medication inhaled to safe levels and adverse reactions are rare. In our experience so far, patients have reported reduced levels of pain and anxiety when using the “green whistle”, which has been supported by other research papers looking at various procedures. The purpose of this study is to determine whether use of Methoxyflurane (Penthrox) plus local anaesthesia for interventional radiology procedures provides better patient experience and procedural outcomes compared to local anaesthesia alone. This has already been shown in other procedures. We hope that showing the benefit of Methoxyflurane (Penthrox) will lead to improved outcomes and patient experiences in the future. Medications, drugs and devices have to be approved for use by the Australian Federal Government. Methoxyflurane (Penthrox) has been approved in Australia for over 30 years, and is specifically validated in Australia to treat: (1) pain in the emergency setting in stable conscious patients presenting after trauma, under the supervision of trained personnel (2) pain in monitored conscious patients who require pain relief (analgesia) for surgical procedures such as the change of dressings. This research is being conducted by the Liverpool Hospital Interventional Radiology Department.
Eligibility
Inclusion Criteria7
- All patients undergoing deep tissue biopsy and insertion or removal of portacaths in the Liverpool Hospital Interventional Radiology Department will be offered participation in the study. Methoxyflurane is routinely used as an adjunct to local anaesthesia for these procedures in our department. Patients must be over 18 years of age and have capacity to provide consent. Written informed voluntary consent will be obtained. Patients must be hemodynamically stable and afebrile.
- deep tissue biopsies
- portacath insertions
- portacath removal
- able to consent
- hemodynamically stable
- afebrile
Exclusion Criteria9
- Low acuity outpatient procedures have deliberately been selected for the purposes of this study. These typically require low levels of sedation. Patients who require definite IV sedation, who are pregnant or in whom it is not appropriate to blind to no sedation will be excluded from the study.
- The research project will be discussed with the patients at the time of consent. It will be clearly explained that they may opt out of the study or deny/withdraw consent at any stage. Patients unable to provide informed, voluntary, competent consent will be excluded. Any patient with allergy or prior adverse reaction to methoxyflurane will not be given methoxyflurane and therefore excluded from the study.
- Patients with impaired renal function (eGFR<50) or liver dysfunction will be excluded as per standard of care for the safe administration of Penthrox® based on the Australia Medical Handbook, Liverpool Hospital protocol and the Australian Therapeutic Goods Administration.
- renal impairment (eGFR<50)
- liver dysfunction
- pregnancy
- opt out or refusal
- definite IV sedation required
- clinically inappropriate to blind to possibility of no additional analgesic adjunct
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Interventions
The MONITOR trial is a prospective double-blind randomised control study comparing the efficacy of methoxyflurane (Penthrox®) vs placebo for interventional radiology procedures. If patients meet the inclusion criteria they will be randomised to receive placebo and local anaesthetic or Penthrox® (1 ampule of 3ml methoxyflurane administered via the “green whistle”) plus local anaesthetic. Patients in both arms of the trial will be educated on safe use of the “green whistle” and be able to use it for the duration of the procedure.
Locations(1)
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ACTRN12623001167651