Pain Clinical Trial
Official title:
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
NCT number | NCT04292808 |
Other study ID # | PRO00040577 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2020 |
Est. completion date | July 2021 |
Verified date | May 2023 |
Source | Verso Surgery Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Verso Surgery Centre | Oakville | Ontario |
Lead Sponsor | Collaborator |
---|---|
Verso Surgery Centre |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessing patient satisfaction | Global assessment of medication performance (gmp) | through study completion, an average of 1 year |
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