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

NCT04292808 | Withdrawn

• 1 other identifier: PRO00040577
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Assessing patient satisfaction

  Global assessment of medication performance (gmp)

  through study completion, an average of 1 year

Study Arms (1)

Penthrox

OTHER

Low Dose Methoxyflurane

Drug: Methoxyflurane

Interventions

Methoxyflurane DRUG

Methoxyflurane inhaler during out-patient aesthetics surgery or facial dermal fillers.

Also known as: Penthrox

Penthrox

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: ≥ 18 years of age
• 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®).
• Patient 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 methoxyflurane use or other halogenated anesthetics
• Hypersensitivity to methoxyflurane 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
• 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

• Verso Surgery Centre: lead

Study Sites (1)

Verso Surgery Centre

Oakville, Ontario, L6J 0A3, Canada

Location

Related Publications (1)

• Romagnoli A, Busque L, Power DJ. The "analgizer" in a general hospital: a preliminary report. Can Anaesth Soc J. 1970 May;17(3):275-8. doi: 10.1007/BF03004607. No abstract available.

  PMID: 5512851 BACKGROUND

Related Links

• Penthrox Data Sheet - New Zealand (2017)

MeSH Terms

Conditions

Pain

Interventions

Methoxyflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)