Health TrialsbyHealthPanel

Methoxyflurane for IUD Insertion and Endometrial Biopsy

ConditionsEndometrial BiopsyIntrauterine Devices
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorMount Sinai Hospital, Canada

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methoxyflurane - Penthrox

    Drug

    3ml of Methoxyflurane via a Penthrox inhaler

  • Placebo Penthrox inhaler

    Other intervention

    3ml of normal saline via an identical placebo Penthrox inhaler

Treatment groups

174 Participants
are divided into 2 treatment groups
Group A: 3ml of MethoxyfluraneExperimental treatment 1 intervention
Group B: 3ml of normal salinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Immediate complications and side effects

Provider-reported via written survey

Time frame
Immediately after the completion of the procedure
3

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
4

Length of time for procedure completion

Recorded via stopwatch

Time frame
During the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mount Sinai Hospital, Canada

Lead sponsor

Matthew Morton Research Award

Collaborator

Source ClinicalTrials.gov
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