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NCT Number: NCT07295054

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.

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Key information

Conditions

IUD

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location status: Recruiting

Location contact

Didem Bozak

CONTACT

[email protected]

416-323-6008

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Methoxyflurane

Drug

3 mL of Methoxyflurane via a handheld inhaler

Other names: Penthrox

Saline

Drug

3 mL of Normal Saline via an identical placebo handheld inhaler

Other names: 0.9% sodium chloride

Primary outcomes

  1. Procedural pain intensity

    Time frame: 20 minutes after post-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).

Secondary outcomes

  1. Patient-centered measure of satisfaction with procedural sedation

    Time frame: 20 minutes after post procedure

    PROcedural Sedation Assessment Survey (PROSAS)

  2. Patient satisfaction with pain management

    Time frame: Baseline before procedure

    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.

  3. Patient distress

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

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

  4. Patient Anxiety

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

    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.

  5. Recall peak pain during procedure

    Time frame: 0 minutes after post 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).

  6. Provider-centered measure of satisfaction with procedural sedation

    Time frame: 20 minutes after post procedure

    PROcedural Sedation Assessment Survey (PROSAS)

  7. Assess the effectiveness of blinding

    Time frame: 20 minutes after post procedure

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

  8. Symptom Reporting / Emergency Visits

    Time frame: 24 hours after post procedure

    Adverse Events recording

  9. Patient Satisfaction with Pain Management

    Time frame: 20 minutes after post procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Didem Bozak

CONTACT

[email protected]

6473814051

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 19, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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