Methoxyflurane for IUD Insertion and Endometrial Biopsy

Mount Sinai Hospital, Canada174 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

174

Conditions

Endometrial Biopsy Intrauterine Devices

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Global pain score

Patient reported pain by the 100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable), higher scores indicate greater pain intensity.

Time frame: 5-minutes following the completion of the procedure

Secondary Outcomes

Pain scores during procedure

Patient-reported verbal pain scores on a scale from 0 (no pain) to 10 (worst pain imaginable) at the following timepoints: baseline before inhaler, baseline after inhaler, insertion of speculum, tap cervix with sound, placement of tenaculum, sounding (IUD only), IUD insertion/endometrial biopsy, and 1-minute post-procedure. Higher scores indicate greater pain intensity.

Time frame: During the procedure

Immediate complications and side effects

Provider-reported via written survey

Time frame: Immediately after the completion of the procedure

Difficulty for provider to complete the procedure

Provider-reported on Likert scale, minimum 1 (least difficult) and maximum 5 (most difficult). Higher score indicates greater difficulty.

Time frame: Immediately after the completion of the procedure

Length of time for procedure completion

Recorded via stopwatch

Time frame: During the procedure

Patient satisfaction

Patient-reported via a written survey

Time frame: Immediately after the completion of the procedure

Patient Satisfaction

Patient-reported via a 5-point Likert scale: very unsatisfied (1) to very satisfied (5). Higher score indicates greater dissatisfaction.

Time frame: Immediately after the completion of the procedure

Methoxyflurane for IUD Insertion and Endometrial Biopsy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes