Clinical trial NCT04412642: Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures
Official title: Pilot Study to Assess the Feasibility of Self-administered Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Acute
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

1. Conscious adult patients \>=
2. 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
   * Visual urethrotomy/bladder neck incision=/- injection of stricture
   * Evaluation of the complex urinary tract problems
3. Patient (patient/or patient's authorization legal representative) should understand the nature of the study and provide written informed consent
4. Patient is able to follow all study requirements and procedures and complete required questionnaires

Exclusion Criteria:

1. An altered level of consciousness, due to any cause, including head injury, drugs,or alcohol
2. Clinically significant renal impairment
3. Women of child bearing potential who are pregnant or peri partum, including labour
4. A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
5. Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
6. Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
7. Exacerbation of an underlying condition (i.e., chronic pain)
8. Clinically evident or potential hemodynamic instability as per the opinion of the investigator
9. Clinically evident respiratory impairment as per the opinion of the investigator
10. Prior treatment with PENTHROX within 3 months

Primary outcomes:
measure: Patient satisfaction measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
timeFrame: end of procedure
Secondary outcomes:
measure: The Overall/Maximum pain intensity experienced at any point during the procedure using a numeric rating scale
timeFrame: during the procedure
measure: Percent patients requiring rescue medication
timeFrame: during the procedure
measure: Safety outcome measure to assess percentage of patients requiring rescue medication
timeFrame: During the procedure;post procedure and at 24 hours post procedure (phone contact)
measure: Health professional impression of how well the medication worked measured using the Patient Global assessment of Medication Performance (GMP)at the time of discharge
timeFrame: end of procedure
measure: Assessment of how well the medication fulfilled the patient's expectations of pain relief using the Fulfillment of of Pain Relief Expectation Scale
timeFrame: end of procedure
measure: 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
timeFrame: end of procedure
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Sender Herschorn, MD, FRSC
role: PRINCIPAL_INVESTIGATOR
References: