Pain, AcutePhase 4NCT04412642
Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures
A Phase 4 study testing Methoxyflurane, MEOF in people with Pain, Acute, run by Sunnybrook Health Sciences Centre.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Methoxyflurane, MEOF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2020to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Conscious adult patients >=
- Patient is scheduled for cystoscopy And:
- BOTOX injections for Overactive Bladder /Neuogenic Detrusor Overactivity,
- Diagnostic hydrodistention for painful bladder syndrome
- Biopsy or cauterization of bladder tumors
- Biopsy, cauterization and/or injection of Hunner's lesions
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- Visual urethrotomy/bladder neck incision=/- injection of stricture
- Evaluation of the complex urinary tract problems
- Patient (patient/or patient's authorization legal representative) should understand the nature of the study and provide written informed consent
- Patient is able to follow all study requirements and procedures and complete required questionnaires
Who cannot join
- An altered level of consciousness, due to any cause, including head injury, drugs,or alcohol
- Clinically significant renal impairment
- Women of child bearing potential who are pregnant or peri partum, including labour
- A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
- Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
- Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
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- Exacerbation of an underlying condition (i.e., chronic pain)
- Clinically evident or potential hemodynamic instability as per the opinion of the investigator
- Clinically evident respiratory impairment as per the opinion of the investigator
- Prior treatment with PENTHROX within 3 months
Trial locations and contacts
No sites are listed yet.
Sender Herschorn, MD,FRSC contact
About this study
Official title: Pilot Study to Assess the Feasibility of Self-administered Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures
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.
Read the detailed description
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
- Conditions
- Pain, Acute
- Being tested
- Methoxyflurane, MEOF
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxyflurane, MEOFDrug
Also called Penthrox
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.
| Study group | Role | What they receive |
|---|---|---|
| methoxyflurane | Other | methoxyflurane Receives: Drug: Methoxyflurane, MEOF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: end of procedure
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start31 May 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sender Herschorn, MD, FRSC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412642
- Sponsor's protocol ID
- 431-2019
- Status last verified
- Jun 2020
- First submitted
- 22 Apr 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Feasibility of Self-administered Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures
- ClinicalTrials.gov ID
- NCT04412642
- Acronym / sponsor ID
- 431-2019
- Conditions
- Pain, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 31 May 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| methoxyflurane | Other | Drug: Methoxyflurane, MEOFmethoxyflurane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Conscious adult patients >=
- Patient is scheduled for cystoscopy And:
- Patient (patient/or patient's authorization legal representative) should understand the nature of the study and provide written informed consent
- Patient is able to follow all study requirements and procedures and complete required questionnaires
Key exclusion criteria (10 listed)
- An altered level of consciousness, due to any cause, including head injury, drugs,or alcohol
- Clinically significant renal impairment
- Women of child bearing potential who are pregnant or peri partum, including labour
- A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
- Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methoxyflurane, MEOFAlso: PenthroxAs 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. | Drug | methoxyflurane |
Primary outcome
Patient satisfaction measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
Time frame: end of procedure
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
6 secondary outcomes
The Overall/Maximum pain intensity experienced at any point during the procedure using a numeric rating scale
Time frame: during the procedure
Percent patients requiring rescue medication
Time frame: during the procedure
Safety outcome measure to assess percentage of patients requiring rescue medication
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
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
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
Time frame: end of procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sender Herschorn, MD,FRSC contact
Sender Herschorn, MD, FRSC principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methoxyflurane, MEOF in people with Pain, Acute, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joanne M Lawrence, RN,BSc. (416-480-6100 ext. 2309, joannelawrence@bell.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge (time frame: end of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.