3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Methoxyflurane
  3 mL of Methoxyflurane via a handheld inhaler
• Препарат Saline
  3 mL of Normal Saline via an identical placebo handheld inhaler

Первичные конечные точки

• Procedural pain intensity [Срок оценки: 20 minutes after post-procedure]

Вторичные конечные точки (9)

• Patient-centered measure of satisfaction with procedural sedation [Срок оценки: 20 minutes after post procedure]
• Patient satisfaction with pain management [Срок оценки: Baseline before procedure]
• Patient distress [Срок оценки: Pre-procedure and post procedure 0,20 minutes and 24 hours.]
• Patient Anxiety [Срок оценки: Pre-procedure and post procedure 0,20 minutes and 24 hours.]
• Recall peak pain during procedure [Срок оценки: 0 minutes after post procedure]
• Provider-centered measure of satisfaction with procedural sedation [Срок оценки: 20 minutes after post procedure]
• Assess the effectiveness of blinding [Срок оценки: 20 minutes after post procedure]
• Symptom Reporting / Emergency Visits [Срок оценки: 24 hours after post procedure]
• Patient Satisfaction with Pain Management [Срок оценки: 20 minutes after post procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Women's College Hospital — Toronto

Идентификаторы

NCT: NCT07295054 · 2025-0056-B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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