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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Any participant ≥18 years and ≤ 65 years presenting for an IUD insertion or endometrial biopsy

• For IUD insertion, only nulliparous patients

• English speaking participants only

• Availability of a ride home from the appointment

Locations
Other Locations
Canada
OPG
RECRUITING
Toronto
Time Frame
Start Date: 2025-07-24
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 174
Treatments
Experimental: 3ml of Methoxyflurane
3ml of Methoxyflurane via a Penthrox inhaler
Placebo_comparator: 3ml of normal saline
3ml of normal saline via an identical placebo Penthrox inhaler
Related Therapeutic Areas
Sponsors
Collaborators: Matthew Morton Research Award
Leads: Mount Sinai Hospital, Canada

This content was sourced from clinicaltrials.gov