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

NCT ID: NCT04292808

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2021-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Penthrox

Low Dose Methoxyflurane

Group Type OTHER

Methoxyflurane

Intervention Type DRUG

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

Interventions

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Methoxyflurane

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

Intervention Type DRUG

Other Intervention Names

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Penthrox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Verso Surgery Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Verso Surgery Centre

Oakville, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 5512851 (View on PubMed)

Related Links

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Other Identifiers

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PRO00040577

Identifier Type: -

Identifier Source: org_study_id

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