The PRICE Trial: Pain Reduction for Intrauterine Contraception Experiment
- Conditions
- Contraception
- Registration Number
- NCT06532162
- Lead Sponsor
- Mount Sinai Hospital, Canada
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 246
Inclusion Criteria:<br><br> - Any participant presenting for an IUD placement, either for contraception or<br> treatment of abnormal uterine bleeding or to regulate menstrual periods<br><br> - All IUDs (copper, hormonal) eligible<br><br> - All parities of patients are eligible<br><br>Exclusion Criteria:<br><br> - Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids,<br> benzodiazepines) within past 24 hours<br><br> - Confirmed pregnancy<br><br> - Any diagnosed chronic pain conditions (fibromyalgia, vaginismus, interstitial<br> cystitis)<br><br> - Misoprostol administration within 24 hours of enrollment<br><br> - Known contraindications to IUD placement<br><br> - Contraindication to lidocaine<br><br> - IUD exchange<br><br> - Previous unsuccessful attempt for IUD by the same practitioner
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Global Pain Score
- Secondary Outcome Measures
Name Time Method Pain at specific pain points;Immediate complications following the procedure (i.e. vasovagal response, dizziness, local anesthetic toxicity syndrome);Length of time for analgesia;Length of time for IUD placement;Patient satisfaction;Difficulty of IUD placement