Methoxyflurane for Pain Relief
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether inhaled methoxyflurane, a type of pain relief medication, is as effective as the usual IV sedation with fentanyl and midazolam for managing pain during certain outpatient gynecological procedures. The main goal is to determine if women experience similar pain relief and can complete their procedures using the inhaled method. Women needing a hysteroscopy due to abnormal or postmenopausal bleeding might be suitable candidates. Participants should not have conditions like sleep apnea or a history of severe liver or kidney issues. As an unphased trial, this study allows participants to contribute to innovative pain management research that could benefit future patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that methoxyflurane is generally safe for pain relief, effectively easing pain without causing kidney or liver issues. No reports link its use to serious side effects, such as hospitalization or death. Methoxyflurane is already approved in Europe for treating moderate-to-severe pain from injuries.
Studies indicate that the intravenous drugs fentanyl and midazolam are safe when used together for sedation. This combination helps individuals relax and feel less anxious during procedures. No major safety concerns have been reported, making them well-tolerated for sedation.
In summary, both methoxyflurane and the fentanyl-midazolam combination have demonstrated good safety records in previous research.12345Why are researchers excited about this trial's treatments?
Methoxyflurane is unique because it offers pain relief through inhalation, using a simple device known as the "green whistle." Unlike standard options like intravenous opioids, methoxyflurane provides rapid analgesia without the need for injections or IV lines. Researchers are excited because this method allows for quick, on-the-spot pain management, which could be especially beneficial in emergency settings or situations where traditional IV access is challenging. Additionally, its non-invasive nature may reduce the risk of complications associated with intravenous treatments.
What evidence suggests that methoxyflurane might be an effective treatment for pain relief during hysteroscopy and/or polypectomy?
Research has shown that inhaled methoxyflurane, which participants in this trial may receive, provides quick and effective pain relief. One study found that almost half of the participants experienced relief after just 1 to 5 breaths. Methoxyflurane acts quickly, often easing pain within 3 to 5 minutes, and has significantly lowered pain levels compared to placebo treatments. In this trial, another group of participants will receive intravenous sedatives such as fentanyl and midazolam, which increase relaxation and reduce anxiety during procedures. These sedatives work together to make procedures more comfortable by lowering awareness and pain.26789
Who Is on the Research Team?
Peter S Thiel, MD MPH FRCSC
Principal Investigator
University of Saskatchewan
Are You a Good Fit for This Trial?
This trial is for women needing a hysteroscopy due to abnormal or postmenopausal bleeding. It's not for those with conditions preventing hysteroscopy, large fibroids, allergies to fentanyl/midazolam, BMI over 42, issues with IV sedation like sleep apnea, no consent given, history of malignant hyperthermia or significant kidney/liver disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either inhaled methoxyflurane or intravenous sedation during hysteroscopy and/or polypectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain assessment and procedure acceptability
Post-procedure Monitoring
Participants are observed for any immediate adverse effects and time to discharge is recorded
What Are the Treatments Tested in This Trial?
Interventions
- Intravenous Sedatives with or Without Analgesia
- Methoxyflurane
Trial Overview
The study compares inhaled methoxyflurane (MOF) against IV conscious sedation using fentanyl and midazolam during outpatient hysteroscopies. The goal is to see if MOF can similarly reduce pain without compromising the procedure's success.
How Is the Trial Designed?
4
Treatment groups
Active Control
Placebo Group
Patients will receive 1 microgram/kg fentanyl and 1 - 3 mg midazolam intravenously as per the normal intravenous sedation protocol
Patients will receive three inhalations from the green whistle loaded with methoxyflurane
Patients in the Methoxyflurane group will receive intravenous saline administered from the same syringes as those in the fentanyl and midazolam group
Patients in the Intravenous sedation group will receive three inhalations of saline from a placebo loaded green whistle
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dr. John A. Thiel Medical Professional Corporation
Lead Sponsor
Published Research Related to This Trial
Citations
Effectiveness and safety of dentist-led conscious sedation ...
Conclusion In this evaluation, the synergistic effects of fentanyl and midazolam resulted in enhanced sedation, anxiolysis and intraoperative ...
Pharmacological agents for procedural sedation and ...
Compared with midazolam-opioids, sedation recovery time is shorter with propofol, patient satisfaction is better with ketamine-propofol, and respiratory ...
Procedural Sedation - StatPearls - NCBI Bookshelf
Procedural sedation and analgesia commonly involve combining a short-acting benzodiazepine, such as midazolam, with an opioid, such as fentanyl.
Administration order of midazolam/fentanyl for moderate ...
This study revealed a 29% reduction in midazolam dosage when low-dose fentanyl opioid was administered first, further demonstrating a ...
Sedation and Analgesia for Pediatric Fracture Reduction in ...
Conclusions Ketamine-midazolam seems to be more effective and have fewer adverse events than fentanyl-midazolam or propofol-fentanyl. Data on other forms of ...
Lidocaine-Midazolam-Fentanyl Combination in Controlling ...
Findings of the present study showed that adding IV lidocaine to IV midazolam + fentanyl drug combination does not provide additional analgesia in sedation for ...
Efficacy and safety of fentanyl in combination with ...
Fentanyl combined with midazolam is safe and more effective than midazolam alone for sedation therapy in mechanically ventilated children.
Stability of Midazolam and Fentanyl in Infusion Solutions
When midazolam and fentanyl are combined, both agents are apparently more than 90% stable for up to 3 hr at room temperature, but the stability of this ...
Sedative-analgesia in ventilated adults: Management ...
Midazolam plus fentanyl maintained sedation level goals better, decreased the dose of the primary agent, added analgesia, and did not ...
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