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IUDPhase 4NCT07295054

3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion

A Phase 4 study testing Methoxyflurane and Saline in people with IUD, run by Women's College Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intrauterine device (IUD) insertion is a common contraceptive procedure often associated with moderate to severe pain, particularly among nulliparous individuals. Current pain management strategies, such as over-the-counter analgesics, are frequently inadequate. Read more about this study

Who is it for?
Ages 18 to 55 years, women only
Conditions the study is for
IUD
What is being tested?
Methoxyflurane and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteCanada
Study dates
27 Apr 2026to 8 Oct 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with a uterus.
  • Ages 18 to 55 years.
  • Undergoing any intrauterine device (IUD) insertion.
  • English-speaking participants.
  • Ability to use an inhaler device.
  • Willing to receive a cervical block for their IUD insertion

Who cannot join

  • Inability to provide informed consent.
  • Confirmed pregnancy.
  • Use of pain medication other than NSAIDs or acetaminophen (e.g., opioids, benzodiazepines, muscle relaxants) within 24 hours prior to the intervention.
  • Use of cannabis within 24 hours prior to the intervention.
  • Administration of misoprostol within 24 hours prior to the intervention.
  • Altered level of consciousness due to any cause, including head injury, drugs, or alcohol.
Show all 12Show fewer
  • History of severe adverse reactions to Penthrox (methoxyflurane) or other halogenated anesthetic agents, or to any ingredient in the formulation (including non-medicinal ingredients or container components).
  • Anatomical variance, such as distorted uterine cavity, bicornuate uterus, uterus didelphys, or cervical stenosis.
  • Clinically significant renal and/or liver impairment.
  • Known or genetic susceptibility to malignant hyperthermia.
  • Clinically evident hemodynamic or cardiovascular instability, or respiratory depression.
  • Not NPO according to hospital guidelines.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2

Other trials in Canada

About this study

Official title: A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion

Intrauterine device (IUD) insertion is a common contraceptive procedure often associated with moderate to severe pain, particularly among nulliparous individuals. Current pain management strategies, such as over-the-counter analgesics, are frequently inadequate. Methoxyflurane, a short-acting, self-administered inhaled analgesic, has been shown to provide rapid and effective pain relief in acute and procedural settings. This study aims to evaluate whether 3 mL of inhaled Methoxyflurane (via Penthrox inhaler) improves patient satisfaction by reducing pain and anxiety during IUD insertion.

Read the detailed description

Methoxyflurane is a short-acting, self-administered inhaled analgesic that has demonstrated rapid and effective pain relief in acute trauma, emergency, and procedural settings. It is non-narcotic, allows patients to control dosing, and does not require intravenous access or prolonged recovery, making it suitable for short outpatient procedures. Existing studies indicate that Methoxyflurane provides faster onset of pain relief compared to standard analgesics, is generally well-tolerated, and has only transient, non-serious adverse effects such as dizziness or headache.

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. The primary objective is to assess patient satisfaction with pain management. Secondary outcomes include procedural pain scores, anxiety levels, and the incidence of adverse events. This trial seeks to provide evidence for an effective, safe, and patient-centered approach to pain management during IUD insertion, potentially improving patient experience and access to long-acting contraceptive options.

Conditions
IUD
Being tested
Methoxyflurane, Saline
Keywords
Methoxyflurane, Penthrox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethoxyfluraneDrug

    Also called Penthrox

    3 mL of Methoxyflurane via a handheld inhaler

  • SalineDrug

    Also called 0.9% sodium chloride

    3 mL of Normal Saline via an identical placebo handheld inhaler

Study groups in NCT07295054
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Drug: Methoxyflurane
Placebo GroupPlacebo comparatorParticipants 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.
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedural pain intensity

    Patient-reported pain will be measured using the Numeric Rating Scale (NRS), a validated tool in which participants rate their pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain).

    Measured: 20 minutes after post-procedure

Secondary outcomes (9)

  1. Patient-centered measure of satisfaction with procedural sedation

    PROcedural Sedation Assessment Survey (PROSAS)

    Measured: 20 minutes after post procedure

  2. Patient satisfaction with pain management

    Pain Catastrophizing Scale (PCS) Purpose: To measure the extent to which individuals magnify, ruminate about, or feel helpless in response to pain.

    Structure:

    13 items rated on a 5-point Likert scale (0 = "not at all" to 4 = "all the time").

    Items are grouped into three subscales:

    Rumination - Focused on the inability to stop thinking about pain. Magnification - Exaggeration of the threat value of pain. Helplessness - Perceived inability to manage pain.

    Scoring:

    Total PCS score ranges from 0 to 52. Higher scores indicate greater pain catastrophizing. Subscale scores can also be calculated for more nuanced insights.

    Measured: Baseline before procedure

  3. Patient distress

    Faces Anxiety Scale Faces are assigned numerical values (e.g., 0-5 or 0-10). Higher scores indicate greater anxiety.

    Measured: Pre-procedure and post procedure 0,20 minutes and 24 hours.

  4. Patient Anxiety

    State-Trait Anxiety Inventory (STAI)

    Structure:

    40 items in total:

    20 items for State Anxiety (S-Anxiety) 20 items for Trait Anxiety (T-Anxiety)

    Respondents rate items on a 4-point Likert scale:

    For State Anxiety: 1 = "Not at all" to 4 = "Very much so" For Trait Anxiety: 1 = "Almost never" to 4 = "Almost always"

    Scoring:

    Each subscale (State and Trait) is scored separately. Higher scores indicate higher levels of anxiety. Scores can be used to track changes over time or to compare anxiety levels across groups.

    Measured: Pre-procedure and post procedure 0,20 minutes and 24 hours.

  5. Recall peak pain during procedure

    Patient-reported pain will be measured using the Numeric Rating Scale (NRS), a validated tool in which participants rate their pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain).

    Measured: 0 minutes after post procedure

  6. Provider-centered measure of satisfaction with procedural sedation

    PROcedural Sedation Assessment Survey (PROSAS)

    Measured: 20 minutes after post procedure

  7. Assess the effectiveness of blinding

    Bang Blinding Index (BBI)- Patient, Assessor and Anesthesia provider

    Measured: 20 minutes after post procedure

  8. Symptom Reporting / Emergency Visits

    Adverse Events recording

    Measured: 24 hours after post procedure

  9. Patient Satisfaction with Pain Management

    Patient-reported satisfaction will be measured on a 5-point scale ranging from 0 (not satisfied) to 10 (very satisfied).

    Measured: 20 minutes after post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2025
  2. Study start27 Apr 2026
  3. Primary completion7 Oct 2026
  4. Study completion8 Oct 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is designed as a double-blind, placebo-controlled randomized controlled trial (RCT) conducted at The Bay Centre for Birth Control Clinic at Women's College Hospital (WCH). The intervention will occur over a single study visit, with data collected at baseline, immediately prior to the procedure, and following the procedure using quantitative survey instruments. Participant recruitment is planned over an 18-month period.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07295054
Sponsor's protocol ID
2025-0056-B
Status last verified
Oct 2026
First submitted
27 Nov 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methoxyflurane and Saline in people with IUD, run by Women's College Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural pain intensity (time frame: 20 minutes after post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07295054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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