IUD
Conditions
Keywords
Methoxyflurane, Penthrox
Brief 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.
Detailed description
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.
Interventions
DRUGMethoxyflurane
3 mL of Methoxyflurane via a handheld inhaler
DRUGSaline
3 mL of Normal Saline via an identical placebo handheld inhaler
Sponsors
Women's College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with a uterus. 2. Ages 18 to 55 years. 3. Undergoing any intrauterine device (IUD) insertion. 4. English-speaking participants. 5. Ability to use an inhaler device. 6. Willing to receive a cervical block for their IUD insertion
Exclusion criteria
1. Inability to provide informed consent. 2. Confirmed pregnancy. 3. Use of pain medication other than NSAIDs or acetaminophen (e.g., opioids, benzodiazepines, muscle relaxants) within 24 hours prior to the intervention. 4. Use of cannabis within 24 hours prior to the intervention. 5. Administration of misoprostol within 24 hours prior to the intervention. 6. Altered level of consciousness due to any cause, including head injury, drugs, or alcohol. 7. History of severe adverse reactions to Penthrox (methoxyflurane) or other halogenated anesthetic agents, or to any ingredient in the formulation (including non-medicinal ingredients or container components). 8. Anatomical variance, such as distorted uterine cavity, bicornuate uterus, uterus didelphys, or cervical stenosis. 9. Clinically significant renal and/or liver impairment. 10. Known or genetic susceptibility to malignant hyperthermia. 11. Clinically evident hemodynamic or cardiovascular instability, or respiratory depression. 12. Not NPO according to hospital guidelines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural pain intensity | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-centered measure of satisfaction with procedural sedation | 20 minutes after post procedure | PROcedural Sedation Assessment Survey (PROSAS) |
| Patient satisfaction with pain management | 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. |
| Patient distress | 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. |
| Patient Anxiety | 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. |
| Recall peak pain during procedure | 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). |
| Provider-centered measure of satisfaction with procedural sedation | 20 minutes after post procedure | PROcedural Sedation Assessment Survey (PROSAS) |
| Assess the effectiveness of blinding | 20 minutes after post procedure | Bang Blinding Index (BBI)- Patient, Assessor and Anesthesia provider |
| Symptom Reporting / Emergency Visits | 24 hours after post procedure | Adverse Events recording |
| Patient Satisfaction with Pain Management | 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). |
Contacts
CONTACTDidem Bozak
PRINCIPAL_INVESTIGATORLauren Scott, NP
Women's College Hospital
PRINCIPAL_INVESTIGATORKarim Ladha, MD
Women's College Hospital
Outcome results
None listed