Health TrialsbyHealthPanel

3 mL Inhaled Methoxyflurane for Intrauterine Device (IUD) Insertion

ConditionIUD
Trial statusCompleted
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorWomen's College Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a uterus.

Ages 18 to 55 years.

Undergoing any intrauterine device (IUD) insertion.

English-speaking participants.

Disqualifiers

Inability to provide informed consent.

Confirmed pregnancy.

Use of pain medication other than NSAIDs or acetaminophen (e.g., opioids, benzodiazepines, muscle relaxants) within 24 hours prior to the intervention.

Use of cannabis within 24 hours prior to the intervention.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methoxyflurane

    Drug

    3 mL of Methoxyflurane via a handheld inhaler

  • Saline

    Drug

    3 mL of Normal Saline via an identical placebo handheld inhaler

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
20 minutes after post-procedure

Secondary outcomes

1

Patient-centered measure of satisfaction with procedural sedation

PROcedural Sedation Assessment Survey (PROSAS)

Time frame
20 minutes after post procedure
2

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.

Time frame
Baseline before procedure
3

Patient distress

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.
4

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.

Time frame
Pre-procedure and post procedure 0,20 minutes and 24 hours.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Women's College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: