Methoxyflurane for Pain Relief in IUD Insertion
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether inhaled Methoxyflurane can reduce pain and stress during IUD insertions. Methoxyflurane, a quick-acting inhaled pain relief option, is already used in other medical settings. The trial includes two groups: one receives the Methoxyflurane inhaler, and the other receives a placebo (a device that looks the same but doesn't relieve pain). It seeks participants with a uterus who plan to get an IUD and are open to using an inhaler and receiving a cervical block for pain management. As a Phase 4 trial, Methoxyflurane is already FDA-approved and proven effective, and this research aims to understand its benefits for more patients.
Will I have to stop taking my current medications?
You may need to stop taking certain medications before the trial. Specifically, you cannot use pain medications other than NSAIDs or acetaminophen, cannabis, or misoprostol within 24 hours before the intervention.
What is the safety track record for Methoxyflurane?
Research has shown that methoxyflurane is generally safe for pain relief during outpatient procedures like IUD insertions. Studies have found that patients tolerate this inhaled pain reliever, often used with a Penthrox inhaler, well. Most people experience only mild side effects, such as dizziness or a slight headache, which typically resolve on their own. Importantly, methoxyflurane has been safely used in other medical settings, reinforcing its reputation as a reliable option for managing pain.12345
Why are researchers enthusiastic about this study treatment?
Methoxyflurane is unique because it offers a fast-acting inhalable option for pain relief during IUD insertion, a procedure often managed by oral NSAIDs or local cervical blocks. Unlike these standard methods, methoxyflurane is delivered through a Penthrox inhaler, allowing patients to self-administer and control their pain relief in real-time. Researchers are excited because this approach not only targets pain swiftly but also provides a non-invasive alternative that could enhance comfort and reduce anxiety during the procedure.
What evidence suggests that Methoxyflurane might be an effective treatment for pain relief during IUD insertion?
Research has shown that methoxyflurane reduces pain during procedures like IUD insertion. In this trial, participants in the intervention group will receive methoxyflurane, an inhaled pain reliever that enables self-managed pain relief. Patients using methoxyflurane have reported significantly less pain compared to other methods. Studies have found it safe and well-tolerated during procedures involving the uterus, such as hysteroscopy. Overall, methoxyflurane presents a promising option for easing discomfort during IUD insertions.16789
Who Is on the Research Team?
Lauren Scott, NP
Principal Investigator
Women's College Hospital
Karim Ladha, MD
Principal Investigator
Women's College Hospital
Are You a Good Fit for This Trial?
This trial is for English-speaking individuals aged 18 to 55 with a uterus who are scheduled for any type of IUD insertion and can use an inhaler device.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 3 mL of inhaled Methoxyflurane or placebo via Penthrox inhaler during IUD insertion
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain and anxiety assessments
What Are the Treatments Tested in This Trial?
Interventions
- Methoxyflurane
Trial Overview
The study compares inhaled Methoxyflurane (a fast-acting pain reliever) versus saline (placebo) to see if it reduces pain and anxiety during IUD insertion. Participants are randomly assigned to one of the two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive a Penthrox inhaler containing 3 mL of methoxyflurane. Before speculum insertion, they will take intermittent inhalations every 30-60 seconds (6-10 breaths), following monograph instructions. They may continue self-administering the inhaler as needed during the procedure. Participants will receive standard pain management prior to IUD insertion, which includes: 1) recommendation to use over-the-counter analgesics such as NSAIDs, and 2) the option to undergo a cervical block to minimize discomfort during the procedure.
Participants will receive an identical-looking inhaler containing 3 mL of normal saline. To maintain blinding, a drop of methoxyflurane will be placed on the outside of the device, which has no analgesic effect. Before speculum insertion, participants will take intermittent inhalations every 30-60 seconds (6-10 breaths), following monograph-style instructions, and may continue self-administering as needed during the procedure. Participants will receive standard pain management prior to IUD insertion, which includes: 1) recommendation to use over-the-counter analgesics such as NSAIDs, and 2) the option to undergo a cervical block to minimize discomfort during the procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Women's College Hospital
Lead Sponsor
Citations
Inhaled methoxyflurane (Penthrox®) as a novel pain relief ...
Conclusion: Penthrox® appears safe, feasible and acceptable as a pain relief option during outpatient hysteroscopy and other intrauterine procedures. The ...
3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) ...
This study aims to evaluate the efficacy of 3 mL of inhaled Methoxyflurane, delivered via Penthrox inhaler, in reducing pain and anxiety during IUD insertion.
Inhaled methoxyflurane (Penthrox®) as a novel pain relief ...
Penthrox® appears safe, feasible and acceptable as a pain relief option during outpatient hysteroscopy and other intrauterine procedures.
Inhaled methoxyflurane (Penthrox®) as a novel pain relief ...
Penthrox® appears safe, feasible and acceptable as a pain relief option during outpatient hysteroscopy and other intrauterine procedures. The ...
Methoxyflurane for Pain During IUD Insertion
Patients using methoxyflurane reported less pain, making it a promising choice for managing discomfort during procedures like IUD insertion or endometrial ...
Healthcare provider's experience of managing pain during ...
This pain is reported throughout all steps of the IUD insertion process, but in particular when the uterus is 'sounded' or measured; when the cervix is ...
Methoxyflurane for IUD Insertion and Endometrial Biopsy
Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Methoxyflurane for Intrauterine Device (IUD) Insertion and Endometrial Biopsy.
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trialx.com
trialx.com/clinical-trials/listings/319429/methoxyflurane-for-iud-insertion-and-endometrial-biopsy/Methoxyflurane for IUD Insertion and Endometrial Biopsy
The aim of this study is to determine if 3ml of inhaled Methoxyflurane, in the form of a Penthrox inhaler, reduces pain during IUD insertion and ...
ANZCTR - Registration
Phase 4, open, single centre, single arm pilot study of methoxyflurane inhalation during outpatient intrauterine device insertion.
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