Methoxyflurane for IUD Insertion and Endometrial Biopsy
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
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
Treatments tested in this trial
- Methoxyflurane - Penthrox
- Placebo Penthrox inhaler
Treatment groups
174 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mount Sinai Hospital, Canada
Lead sponsor
Matthew Morton Research Award
Collaborator
Source ClinicalTrials.gov