RecruitingNot ApplicableNCT07046572

Methoxyflurane for IUD Insertion and Endometrial Biopsy

A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3ml Methoxyflurane for Intrauterine Device (IUD) Insertion and Endometrial Biopsy


Sponsor

Mount Sinai Hospital, Canada

Enrollment

174 participants

Start Date

Jul 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether inhaling Methoxyflurane (a fast-acting pain reliever available through a handheld Penthrox inhaler) reduces pain during IUD insertion or endometrial biopsy compared to a placebo inhaler. These are common gynecological procedures that can be uncomfortable, and the study is looking for better non-opioid options for pain relief. You may be eligible if you are 18 to 65 years old, scheduled for an IUD insertion (first-time insertions only) or endometrial biopsy, speak English, and do not have chronic pain conditions, liver or kidney disease, or an allergy to methoxyflurane. Participation involves inhaling the assigned medication just before your procedure and rating your pain level 5 minutes afterward. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethoxyflurane - Penthrox

3ml of Methoxyflurane via a Penthrox inhaler

OTHERPlacebo Penthrox inhaler

3ml of normal saline via an identical placebo Penthrox inhaler


Locations(1)

OPG

Toronto, Ontario, Canada

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NCT07046572


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