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3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion

NCT ID: NCT07295054

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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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

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IUD

Keywords

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Methoxyflurane Penthrox

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
As noted above, only the individual preparing the intervention will be aware of allocation assignment. The participant, IUD provider, anesthesia provider and outcomes assessors will be blinded to minimize bias.

Study Groups

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Intervention 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.

Group Type EXPERIMENTAL

Penthrox

Intervention Type DRUG

3 mL of Methoxyflurane via a handheld inhaler

Placebo Group

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.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

3 mL of Normal Saline via an identical placebo handheld inhaler

Interventions

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Penthrox

3 mL of Methoxyflurane via a handheld inhaler

Intervention Type DRUG

Saline

3 mL of Normal Saline via an identical placebo handheld inhaler

Intervention Type DRUG

Other Intervention Names

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methoxyflurane

Eligibility Criteria

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Inclusion Criteria

1. Patients with a uterus.
2. Ages 18 to 55 years.
3. Undergoing any intrauterine device (IUD) insertion.
4. English-speaking participants.
5. Ability to use an inhaler device.

Exclusion Criteria

1. Inability to provide informed consent.
2. Confirmed pregnancy.
3. Use of pain medication other than NSAIDs or acetaminophen (e.g., opioids, benzodiazepines, muscle relaxants) within 24 hours prior to the intervention.
4. Use of cannabis within 24 hours prior to the intervention.
5. Administration of misoprostol within 24 hours prior to the intervention.
6. Altered level of consciousness due to any cause, including head injury, drugs, or alcohol.
7. 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).
8. Anatomical variance, such as distorted uterine cavity, bicornuate uterus, uterus didelphys, or cervical stenosis.
9. Clinically significant renal and/or liver impairment.
10. Known or genetic susceptibility to malignant hyperthermia.
11. Clinically evident hemodynamic or cardiovascular instability, or respiratory depression.
12. Not NPO according to hospital guidelines.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Women's College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren Scott, NP

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Central Contacts

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Didem Bozak

Role: CONTACT

Phone: 6473814051

Email: [email protected]

Other Identifiers

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2025-0056-B

Identifier Type: -

Identifier Source: org_study_id