Women's College Hospital
Toronto, Ontario, M5S 1B2, Canada
Location status: Recruiting
NCT Number: NCT07295054
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.
Interested in participating?
Request Info18 year–55 year
Female
Interventional
Phase 4
Toronto, Ontario, M5S 1B2, Canada
Location status: Recruiting
Methoxyflurane is a short-acting, self-administered inhaled analgesic that has demonstrated rapid and effective pain relief in acute trauma, emergency, and procedural settings. It is non-narcotic, allows patients to control dosing, and does not require intravenous access or prolonged recovery, making it suitable for short outpatient procedures. Existing studies indicate that Methoxyflurane provides faster onset of pain relief compared to standard analgesics, is generally well-tolerated, and has only transient, non-serious adverse effects such as dizziness or headache.
This study aims to evaluate the efficacy of 3 mL of inhaled Methoxyflurane, delivered via Penthrox inhaler, in reducing pain and anxiety during IUD insertion. The primary objective is to assess patient satisfaction with pain management. Secondary outcomes include procedural pain scores, anxiety levels, and the incidence of adverse events. This trial seeks to provide evidence for an effective, safe, and patient-centered approach to pain management during IUD insertion, potentially improving patient experience and access to long-acting contraceptive options.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3 mL of Methoxyflurane via a handheld inhaler
Other names: Penthrox
3 mL of Normal Saline via an identical placebo handheld inhaler
Other names: 0.9% sodium chloride
Time frame: 20 minutes after post-procedure
Patient-reported pain will be measured using the Numeric Rating Scale (NRS), a validated tool in which participants rate their pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 20 minutes after post procedure
PROcedural Sedation Assessment Survey (PROSAS)
Time frame: Baseline before procedure
Pain Catastrophizing Scale (PCS) Purpose: To measure the extent to which individuals magnify, ruminate about, or feel helpless in response to pain.
Structure:
13 items rated on a 5-point Likert scale (0 = "not at all" to 4 = "all the time").
Items are grouped into three subscales:
Rumination - Focused on the inability to stop thinking about pain. Magnification - Exaggeration of the threat value of pain. Helplessness - Perceived inability to manage pain.
Scoring:
Total PCS score ranges from 0 to 52. Higher scores indicate greater pain catastrophizing. Subscale scores can also be calculated for more nuanced insights.
Time frame: Pre-procedure and post procedure 0,20 minutes and 24 hours.
Faces Anxiety Scale Faces are assigned numerical values (e.g., 0-5 or 0-10). Higher scores indicate greater anxiety.
Time frame: Pre-procedure and post procedure 0,20 minutes and 24 hours.
State-Trait Anxiety Inventory (STAI)
Structure:
40 items in total:
20 items for State Anxiety (S-Anxiety) 20 items for Trait Anxiety (T-Anxiety)
Respondents rate items on a 4-point Likert scale:
For State Anxiety: 1 = "Not at all" to 4 = "Very much so" For Trait Anxiety: 1 = "Almost never" to 4 = "Almost always"
Scoring:
Each subscale (State and Trait) is scored separately. Higher scores indicate higher levels of anxiety. Scores can be used to track changes over time or to compare anxiety levels across groups.
Time frame: 0 minutes after post procedure
Patient-reported pain will be measured using the Numeric Rating Scale (NRS), a validated tool in which participants rate their pain intensity on a scale from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 20 minutes after post procedure
PROcedural Sedation Assessment Survey (PROSAS)
Time frame: 20 minutes after post procedure
Bang Blinding Index (BBI)- Patient, Assessor and Anesthesia provider
Time frame: 24 hours after post procedure
Adverse Events recording
Time frame: 20 minutes after post procedure
Patient-reported satisfaction will be measured on a 5-point scale ranging from 0 (not satisfied) to 10 (very satisfied).
Contact information is provided by the study sponsor or research team.
Women's College Hospital
Other
A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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