Methoxyflurane for IUD Insertion and Endometrial Biopsy

Phase

N/A

Condition

Birth Control

Endometrial Cancer

Contraception

Treatment

Methoxyflurane - Penthrox

Placebo Penthrox inhaler

Clinical Study ID

NCT07046572

REB 25-0041-A

Ages 18-65
Female
Accepts Healthy Volunteers

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:

Intervention (3ml of Methoxyflurane via a Penthrox inhaler)
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 Criteria

Inclusion

Inclusion Criteria

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

Exclusion Criteria

Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
Misoprostol administration within 24 hours
Breastfeeding
Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)
Allergy to methoxyflurane
Renal or liver disease
Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
Baseline vital signs of systolic blood pressure <100, diastolic blood pressure <60 and/or pulse <60.
Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible)
Clinically evident respiratory impairment

Study Design