Methoxyflurane for IUD Insertion and Endometrial Biopsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methoxyflurane - Penthrox, Placebo Penthrox inhaler.
- Who it may be relevant to
- Registry conditions: Endometrial Biopsy, Intrauterine Devices. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3ml Methoxyflurane for Intrauterine Device (IUD) Insertion and Endometrial Biopsy
Overview
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).
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
Primary outcome measures
- Global pain score [Time frame: 5-minutes following the completion of the procedure]
Secondary outcome measures (6)
- Pain scores during procedure [Time frame: During the procedure]
- Immediate complications and side effects [Time frame: Immediately after the completion of the procedure]
- Difficulty for provider to complete the procedure [Time frame: Immediately after the completion of the procedure]
- Length of time for procedure completion [Time frame: During the procedure]
- Patient satisfaction [Time frame: Immediately after the completion of the procedure]
- Patient Satisfaction [Time frame: Immediately after the completion of the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Other
Study locations
Canada · 1 center
- OPG — Toronto
Identifiers
NCT: NCT07046572 · REB 25-0041-A