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Methoxyflurane for IUD Insertion and Endometrial Biopsy

NCT07046572 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-07-30

No results posted yet for this study

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

DRUG

Methoxyflurane - Penthrox

3ml of Methoxyflurane via a Penthrox inhaler

OTHER

Placebo Penthrox inhaler

3ml of normal saline via an identical placebo Penthrox inhaler

Sponsors & Collaborators

  • Matthew Morton Research Award

    collaborator UNKNOWN

  • Mount Sinai Hospital, Canada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2025-12-01
Completion
2026-03-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07046572 on ClinicalTrials.gov