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

Study Overview
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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).

Official Title
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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

Conditions
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Pain

Intervention / Treatment
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* Drug: Methoxyflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Penthrox<br>Low Dose Methoxyflurane | Drug: Methoxyflurane<br>* Methoxyflurane inhaler during out-patient aesthetics surgery or facial dermal fillers.<br>* Other names: Penthrox;|

What is the study measuring?
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Primary Outcome Measures

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