A Phase 4 interventional study of Methoxyflurane, MEOF in Pain, Acute, sponsored by Sunnybrook Health Sciences Centre. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-02.
Sponsored by Sunnybrook Health Sciences Centre · Phase 4, Interventional, and Treatment
The participant will be trained to self administer the drug and will be supplied with a PENTHROX commercial inhaler kit .The study nurse will train the participant and supervise its use during the procedure.Immediately following the procedure the participant will be asked to fill out two brief questionnaires. The study nurse will assess the participant for adverse event and will follow-up with a phone call 24 hours later.
Many patients with chronic urological conditions require multiple and sometimes painful urological procedures. Ideally these procedures may be done in the cystoscopy suite without a general anesthetic. Low dose methoxyflurane, (MEOF)is a inhaled, self-administered non-opioid analgesic and has been approved by Health Canada's for the short-term relief of moderate to severe acute pain, associated with trauma or international medical procedures, in conscious adult patients. The brand name is PENTHROX.
This study is a single centre, pilot study to assess the feasibility of using a self-administrated, MEOF for pain relief during minor out-patient urological procedures. Eligible participants will receive a one time dose of the the study medication during a planned, outpatient urological procedure done under cystoscopy in the Cystoscopy clinic
908 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's planned enrollment of 10 is below the median of 87 across 759 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Sunnybrook Health Sciences Centre is the lead sponsor of 582 studies on the registry; 133 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient is scheduled for cystoscopy And:
Exclusion Criteria:
methoxyflurane
Drug: Methoxyflurane, MEOF
As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber.
Also known as: Penthrox
Patient satisfaction measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
Global assessment of Medication,which is an assessment, performed by the patient, of the patient's impression of how well the medication works. The patient is asked to rate the pain relief given by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Time frame: end of procedure
The Overall/Maximum pain intensity experienced at any point during the procedure using a numeric rating scale
Patient is asked to rate the intensity of the pain experienced using an 11-point numeric rating scale is used. A score of 0=no pain and a score of 10= worst pain possible
Time frame: during the procedure
Percent patients requiring rescue medication
Documentation of the use of rescue medication post administration of methooxyflurane Documenting first time of use of rescue medication, type of medication administered,dose and route
Time frame: during the procedure
Safety outcome measure to assess percentage of patients requiring rescue medication
Documentation of adverse events as safety outcome measure by the health care professional
Time frame: During the procedure;post procedure and at 24 hours post procedure (phone contact)
Health professional impression of how well the medication worked measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
Global assessment of Medication Performance, is an assessment, performed by the health care professional, of their impression of how well the medication works. The health care professional is asked a single question "rate the pain relief provided by methoxyflurane using a 5-point likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Time frame: end of procedure
Assessment of how well the medication fulfilled the patient's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale
The patient is asked a single question "To what extent has your expectations regarding pain control been met?", using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Time frame: end of procedure
Assessment of how well the medication fulfilled the health care professional's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale
The health care professional is asked a single question "To what extent has your expectations regarding pain control been met?", using the Fulfillment of Pain Relief Expectation scale, which uses a 5-point Likert scale - 0=poor;1=fair;2=good;3=very good;4=excellent
Time frame: end of procedure
No study locations are listed for this record.
This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Methoxyflurane
Sunnybrook Health Sciences Centre →