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

Verso Surgery Centre1 site in 1 countryJuly 2020

ConditionsPain

InterventionsMethoxyflurane

DrugsMethoxyflurane

Overview

Phase: Not Applicable
Intervention: Methoxyflurane
Conditions: Pain
Sponsor: Verso Surgery Centre
Locations: 1
Primary Endpoint: Assessing patient satisfaction
Status: Withdrawn
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 2020

End Date

July 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Verso Surgery Centre

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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