Methoxyflurane for IUD Insertion and Endometrial Biopsy

Not Applicable

Recruiting

• Conditions: Intrauterine Devices; Endometrial Biopsy

• Registration Number: NCT07046572
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-20
• Study Start: 2025-06-26
• Study First Submitted QC: 2025-06-27
• Last Update Submitted: 2025-06-27
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 174

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global pain score	5-minutes following the completion of the procedure	Patient reported pain by the 100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable), higher scores indicate greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
Pain scores during procedure	During the procedure	Patient-reported verbal pain scores on a scale from 0 (no pain) to 10 (worst pain imaginable) at the following timepoints: baseline before inhaler, baseline after inhaler, insertion of speculum, tap cervix with sound, placement of tenaculum, sounding (IUD only), IUD insertion/endometrial biopsy, and 1-minute post-procedure. Higher scores indicate greater pain intensity.
Immediate complications and side effects	Immediately after the completion of the procedure	Provider-reported via written survey
Difficulty for provider to complete the procedure	Immediately after the completion of the procedure	Provider-reported on Likert scale, minimum 1 (least difficult) and maximum 5 (most difficult). Higher score indicates greater difficulty.
Length of time for procedure completion	During the procedure	Recorded via stopwatch
Patient satisfaction	Immediately after the completion of the procedure	Patient-reported via a written survey
Patient Satisfaction	Immediately after the completion of the procedure	Patient-reported via a 5-point Likert scale: very unsatisfied (1) to very satisfied (5). Higher score indicates greater dissatisfaction.

Trial Locations

Locations (1)

OPG; 🇨🇦 Toronto, Ontario, Canada