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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Acute
• Intervention / Treatment: Drug: Methoxyflurane, MEOF

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joanne M Lawrence, RN,BSc.; Phone Number: 2309 416-480-6100; Email: joannelawrence@bell.net
• Study Contact Backup: Name: Sender Herschorn, MD,FRSC; Phone Number: 416-480-4733

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: methoxyflurane

Drug: 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.; Other Names: Penthrox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Sender Herschorn, MD, FRSC, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): May 31, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: April 22, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Methoxyflurane
• Other Study ID Numbers: 431-2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No