Evaluating 3 mL Inhaled Methoxyflurane for Pain and Anxiety Relief During Intrauterine Device Insertion A Double-Blind, Placebo-Controlled Phase 4 Study in Women Aged 18 to 55

What this Trial Is About

Researchers are evaluating the use of inhaled Methoxyflurane, a short-acting and self-administered pain reliever, to improve comfort during intrauterine device IUD insertion. This trial focuses on women aged 18 to 55 undergoing IUD insertion, aiming to assess whether 3 mL of Methoxyflurane can reduce pain and anxiety and improve patient satisfaction compared to a placebo. The study is a double-blind, randomized controlled trial sponsored by Womens College Hospital. Participants are randomly assigned to receive either a Penthrox inhaler with 3 mL of Methoxyflurane or an identical inhaler containing saline as a placebo. Both groups follow a self-inhalation schedule before speculum insertion and may continue as needed during the procedure. Standard pain management is also provided, including recommendations for over-the-counter pain relievers and the option for a cervical block to help reduce discomfort. During the study, participants will be monitored for pain intensity, anxiety, distress, and satisfaction with pain management at various times before, during, and after the procedure, including up to 24 hours later. Researchers will also track any adverse effects or emergency visits. The main outcome is procedural pain intensity measured 20 minutes after the procedure, with additional assessments of patient and provider satisfaction and the effectiveness of blinding. The trial is expected to run until February 2027.

3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion