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

NCT04412642 | Unknown Phase 4

• 1 other identifier: 431-2019
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• The Overall/Maximum pain intensity experienced at any point during the procedure using a numeric rating scale

  during the procedure

• Percent patients requiring rescue medication

  during the procedure

• Safety outcome measure to assess percentage of patients requiring rescue medication

  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

  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

  end of procedure

Study Arms (1)

methoxyflurane

OTHER

methoxyflurane

Drug: Methoxyflurane, MEOF

Interventions

Methoxyflurane, MEOF 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.

Also known as: Penthrox

methoxyflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

MeSH Terms

Conditions

Acute Pain

Interventions

Methoxyflurane

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers

Study Officials

• Sender Herschorn, MD, FRSC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne M Lawrence, RN,BSc.

CONTACT

416-480-6100; joannelawrence@bell.net

Sender Herschorn, MD,FRSC

CONTACT

416-480-4733

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: June 2, 2020
• Study Start: May 31, 2020
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-06