RecruitingPhase 3ACTRN12623001127695

PROMPT: PROcedural sedation vs Methoxyflurane a Prospective cohorT Study.

Prospective randomised double arm study comparing safety, pain and anxiety outcomes between methoxyflurane vs intravenous fentanyl and midazolam for patients requiring interventional radiological procedures


Sponsor

South Western Sydney Local Health District Human Research Ethics Committee

Enrollment

150 participants

Start Date

Aug 11, 2021

Study Type

Interventional

Conditions

Summary

Procedures performed in interventional radiology are often quick and minimally invasive, however some procedures traditionally require increased pain relief and sedation than local anaesthetic alone. For these procedures, we have previously used intravenous medications (midazolam and fentanyl) for sedation and pain relief; however, dosing of these medications is controlled by your nurse or doctor which can lead to under or over dosing of medications, or delayed pain relief due to delays in administration of medication. We believe that letting the patient control how much medication and how often can be effective.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

The PROMPT Study is comparing two approaches to pain relief and sedation for patients undergoing procedures in the interventional radiology department — procedures like biopsies, drain insertions, or catheter placements that can cause discomfort. One approach uses traditional intravenous medications (midazolam and fentanyl) given by the medical team. The other approach uses methoxyflurane (a pain-relieving inhaler, brand name Penthrox), which the patient controls themselves by inhaling as needed. The key question is whether patient-controlled inhaled pain relief is as effective and safe as team-administered intravenous sedation, and whether it leads to a better experience for patients. Self-controlled pain relief may reduce the risk of over- or under-dosing and may give patients more comfort and control during procedures. You may be eligible if you are over 18, are awake and able to consent, need more than just local anaesthetic for a procedure at Liverpool Hospital's Interventional Radiology department, and your procedure is expected to take less than two hours. People with allergies to these medications, kidney or liver problems, pregnancy, or who require general anaesthesia are not eligible. This study could help make minimally invasive procedures more comfortable and patient-centred.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Prospective randomised double arm study comparing methoxyflurane vs intravenous fentanyl and midazolam for patients requiring periprocedural analgesia or sedation. Penthrox® (1 ampule of 3ml methox

Prospective randomised double arm study comparing methoxyflurane vs intravenous fentanyl and midazolam for patients requiring periprocedural analgesia or sedation. Penthrox® (1 ampule of 3ml methoxyflurane administered via the “green whistle”) plus local anaesthetic. Patients will be educated on safe use of the “green whistle” and be able to use it for the duration of the procedure.


Locations(1)

Liverpool Hospital - Liverpool

NSW, Australia

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ACTRN12623001127695