NCT07046572

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Endometrial Biopsy
• Intrauterine Devices

Interventions

Type	Name	Description
DRUG	Methoxyflurane - Penthrox	3ml of Methoxyflurane via a Penthrox inhaler
OTHER	Placebo Penthrox inhaler	3ml of normal saline via an identical placebo Penthrox inhaler

Timeline

• Start date: 2025-07-24
• Primary completion: 2025-12-01
• Completion: 2026-03-01
• First posted: 2025-07-01
• Last updated: 2025-07-30

Locations

1 site across 1 country: Canada