Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date May 2023
Source Verso Surgery Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Withdrawn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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Verso Surgery Centre Oakville Ontario

Sponsors (1)

Lead Sponsor Collaborator
Verso Surgery Centre

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care