Low Dose Methoxyflurane for Pain Relief During Minor Out-patient Urologic Procedures

NCT ID: NCT04412642

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2020-12-31

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

Conditions

Pain, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

methoxyflurane

methoxyflurane

Group Type: OTHER

Methoxyflurane, MEOF

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Penthrox

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sender Herschorn, MD, FRSC

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Central Contacts

Joanne M Lawrence, RN,BSc.

Role: CONTACT

joannelawrence@bell.net

416-480-6100 ext. 2309

Sender Herschorn, MD,FRSC

Role: CONTACT

416-480-4733

Other Identifiers

431-2019

Identifier Type: -

Identifier Source: org_study_id