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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methoxyflurane | Other | methoxyflurane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxyflurane, MEOF | Drug | As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROXâ„¢ 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. PENTHROXâ„¢ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROXâ„¢ inhaler with the Activated Carbon (AC) chamber. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | end of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | during the procedure |
| Percent patients requiring rescue medication |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanne M Lawrence, RN,BSc. | Contact | 416-480-6100 | 2309 | joannelawrence@bell.net |
| Sender Herschorn, MD,FRSC | Contact | 416-480-4733 |
| Name | Affiliation | Role |
|---|---|---|
| Sender Herschorn, MD, FRSC | Sunnybrook Health Sciences Centre | Principal Investigator |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008733 | Methoxyflurane |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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no masking
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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 |
| 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 | 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 | 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 | 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 | end of procedure |