Low Dose Methoxyflurane and Out-Patient Aesthetic Surgery and Facial Filler

May 3, 2023 updated by: Verso Surgery Centre

An Open-Label Study to Assess the Efficacy and Safety of Low Dose Methoxyflurane (PENTHROX®) for Pain Control During Outpatient Aesthetic Surgeries and Facial Filler Injections

The aim of the study is to generate real-world evidence on the effectiveness, safety and additional parameters of low dose methoxyflurane (PENTHROX®) in: aesthetic surgeries (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) and facial filler injections [eg. hyaluronic acid (HA) and Sculptra®] in an outpatient aesthetic practice. This will be an open-label study, with a total of 60 patients undergoing a planned outpatient aesthetic surgery or filler injection (30 patients in each group).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Oakville, Ontario, Canada, L6J 0A3
        • Verso Surgery Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr. Jack Kolenda, MD, FRCS (C)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Conscious adult patients: ≥ 18 years of age
  2. Patient is scheduled for an outpatient anesthetic surgery (eg. hair transplant, upper blepharoplasty, otoplasty, upper brow lift, and mentoplasty) or a facial filler injection (eg. HA, and Sculptra®).
  3. Patient 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 methoxyflurane use or other halogenated anesthetics
  5. Hypersensitivity to methoxyflurane 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. Clinically evident or potential hemodynamic instability as per the opinion of the investigator
  8. Clinically evident respiratory impairment as per the opinion of the investigator
  9. Prior treatment with PENTHROX® within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Penthrox
Low Dose Methoxyflurane
Drug: Methoxyflurane
Methoxyflurane inhaler during out-patient aesthetics surgery or facial dermal fillers.
Other Names:
  • Penthrox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing patient satisfaction
Time Frame: through study completion, an average of 1 year
Global assessment of medication performance (gmp)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verso Surgery Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00040577

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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