Intrauterine Device Insertion Clinical Trials

Clinical trials related to Intrauterine Device Insertion Procedure

A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Intrauterine device (IUD) insertion is a common contraceptive procedure often associated with moderate to severe pain, particularly among nulliparous individuals. Current pain management strategies, such as over-the-counter analgesics, are frequently inadequate. Methoxyflurane, a short-acting, self-administered inhaled analgesic, has been shown to provide rapid and effective pain relief in acute and procedural settings. This study aims to evaluate whether 3 mL of inhaled Methoxyflurane (via Penthrox inhaler) improves patient satisfaction by reducing pain and anxiety during IUD insertion.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Patients with a uterus.

• Ages 18 to 55 years.

• Undergoing any intrauterine device (IUD) insertion.

• English-speaking participants.

• Ability to use an inhaler device.

• Willing to receive a cervical block for their IUD insertion

Locations
Other Locations
Canada
Women's College Hospital
RECRUITING
Toronto
Contact Information
Primary
Didem Bozak
didem.bozak@wchospital.ca
6473814051
Time Frame
Start Date: 2026-04-27
Estimated Completion Date: 2027-02
Participants
Target number of participants: 110
Treatments
Experimental: Intervention Group
Participants will receive a Penthrox inhaler containing 3 mL of methoxyflurane. Before speculum insertion, they will take intermittent inhalations every 30-60 seconds (6-10 breaths), following monograph instructions. They may continue self-administering the inhaler as needed during the procedure.~Participants will receive standard pain management prior to IUD insertion, which includes: 1) recommendation to use over-the-counter analgesics such as NSAIDs, and 2) the option to undergo a cervical block to minimize discomfort during the procedure.
Placebo_comparator: Placebo Group
Participants will receive an identical-looking inhaler containing 3 mL of normal saline. To maintain blinding, a drop of methoxyflurane will be placed on the outside of the device, which has no analgesic effect. Before speculum insertion, participants will take intermittent inhalations every 30-60 seconds (6-10 breaths), following monograph-style instructions, and may continue self-administering as needed during the procedure.~Participants will receive standard pain management prior to IUD insertion, which includes: 1) recommendation to use over-the-counter analgesics such as NSAIDs, and 2) the option to undergo a cervical block to minimize discomfort during the procedure.
Related Therapeutic Areas
Sponsors
Leads: Women's College Hospital

This content was sourced from clinicaltrials.gov