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Methoxyflurane for IUD Insertion and Endometrial Biopsy

RecruitingNAAges 18 Years - 65 YearsFemaleMount Sinai Hospital, Canada
NCT07046572 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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/or endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT. Each participant will be randomly assigned to one of two arms: 1. Intervention (3ml of Methoxyflurane via a Penthrox inhaler) 2. Placebo (3ml of normal saline via an identical placebo Penthrox inhaler) The primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).

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📋 Eligibility rules (as published)
Inclusion Criteria * Any participant ≥18 years and ≤ 65 years presenting for an IUD insertion or endometrial biopsy * For IUD insertion, only nulliparous patients * English speaking participants only * Availability of a ride home from the appointment Exclusion Criteria * Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours * Misoprostol administration within 24 hours * Breastfeeding * Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus) * Allergy to methoxyflurane * Renal or liver disease * Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives * Baseline vital signs of systolic blood pressure \<100, diastolic blood pressure \<60 and/or pulse \<60. * Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible) * Clinically evident respiratory impairment
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What it tests

  • Methoxyflurane - Penthrox
  • Placebo Penthrox inhaler
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Where

1 site
OPG
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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