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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
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| Placebo Group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxyflurane | Drug | 3 mL of Methoxyflurane via a handheld inhaler |
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| Measure | Description | Time Frame |
|---|---|---|
| Procedural pain intensity | 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). | 20 minutes after post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-centered measure of satisfaction with procedural sedation | PROcedural Sedation Assessment Survey (PROSAS) | 20 minutes after post procedure |
| Patient satisfaction with pain management | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Didem Bozak | Contact | 6473814051 | didem.bozak@wchospital.ca |
| Name | Affiliation | Role |
|---|---|---|
| Lauren Scott, NP | Women's College Hospital | Principal Investigator |
| Karim Ladha, MD | Women's College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's College Hospital | Recruiting | Toronto | Ontario | M5S 1B2 | Canada |
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| ID | Term |
|---|---|
| D008733 | Methoxyflurane |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D005019 | Ethyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
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This study is designed as a double-blind, placebo-controlled randomized controlled trial (RCT) conducted at The Bay Centre for Birth Control Clinic at Women's College Hospital (WCH). The intervention will occur over a single study visit, with data collected at baseline, immediately prior to the procedure, and following the procedure using quantitative survey instruments. Participant recruitment is planned over an 18-month period.
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As noted above, only the individual preparing the intervention will be aware of allocation assignment. The participant, IUD provider, anesthesia provider and outcomes assessors will be blinded to minimize bias.
| Saline | Drug | 3 mL of Normal Saline via an identical placebo handheld inhaler |
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| Baseline before procedure |
| Patient distress | Faces Anxiety Scale Faces are assigned numerical values (e.g., 0-5 or 0-10). Higher scores indicate greater anxiety. | Pre-procedure and post procedure 0,20 minutes and 24 hours. |
| Patient Anxiety | 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. | Pre-procedure and post procedure 0,20 minutes and 24 hours. |
| Recall peak pain during 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). | 0 minutes after post procedure |
| Provider-centered measure of satisfaction with procedural sedation | PROcedural Sedation Assessment Survey (PROSAS) | 20 minutes after post procedure |
| Assess the effectiveness of blinding | Bang Blinding Index (BBI)- Patient, Assessor and Anesthesia provider | 20 minutes after post procedure |
| Symptom Reporting / Emergency Visits | Adverse Events recording | 24 hours after post procedure |
| Patient Satisfaction with Pain Management | Patient-reported satisfaction will be measured on a 5-point scale ranging from 0 (not satisfied) to 10 (very satisfied). | 20 minutes after post procedure |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |