Status:

UNKNOWN

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

Lead Sponsor:

Sunnybrook Health Sciences Centre

Conditions:

Pain, Acute

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 pro...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

May 31 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2020

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04412642

Start Date

May 31 2020

End Date

December 31 2020

Last Update

June 2 2020

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