Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
Healthy Volunteers
NCT07046572

Methoxyflurane for IUD Insertion and Endometrial Biopsy

Led by Mount Sinai Hospital, Canada · Updated on 2025-07-30

174

Participants Needed

1

Research Sites

31 weeks

Total Duration

On this page

Sponsors

M

Mount Sinai Hospital, Canada

Lead Sponsor

M

Matthew Morton Research Award

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Methoxyflurane for IUD Insertion and Endometrial Biopsy

Who Can Participate

Age: 18Years - 65Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 18 to 65 years presenting for IUD insertion or endometrial biopsy
  • Only nulliparous patients for IUD insertion
  • English speaking participants
  • Availability of a ride home after the appointment
Not Eligible

You will not qualify if you...

  • Use of pain medication other than NSAIDs or acetaminophen within past 24 hours
  • Misoprostol use within 24 hours
  • Currently breastfeeding
  • Diagnosed chronic pain syndromes such as fibromyalgia or vaginismus
  • Allergy to methoxyflurane
  • Renal or liver disease
  • Known or genetic susceptibility to malignant hyperthermia or severe adverse reactions in patient or relatives
  • Baseline low vital signs: systolic blood pressure less than 100, diastolic less than 60, or pulse less than 60
  • Previous unsuccessful office attempt at IUD insertion or endometrial biopsy by the same practitioner
  • Clinically evident respiratory impairment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

OPG

Toronto, Ontario, Canada, M5G 1Z5

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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