Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of 2% Lidocaine Gel for IUD Insertion
Brief Summary: The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled trials have been shown to be effective in reducing pain during IUD insertion. While many women tolerate IUD insertion well, others have moderate to severe pain. This double-blind randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a 15 mm difference on the VAS with our sample size. Other data to be collected include information regarding age, BMI, obstetric history, lactation status, time since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated pain levels, insertion characteristics (time, difficulty, complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily administered option for pain control will be available to providers and patients.


Options:
A: Inclusion Criteria:

* Nulliparous, no prior pregnancy beyond 14 week
* Over 18 years of age
* Negative pregnancy test

Exclusion Criteria:

* current pregnancy or pregnancy within 6 weeks
* current cervicitis or PID (active or within 3 months)
* undiagnosed abnormal uterine bleeding
* allergy to copper/ Wilson's disease (for Paragard)
* cervical or uterine cancer
* uterine anomaly altering uterine cavity
B: Inclusion Criteria:

* 18 years
* negative pregnancy test
* no prior pregnancy beyond 19 6/7 weeks
* no pelvic inflammatory disease in last 3 months
* no current cervicitis
* willing to follow up in 1-2 months

Exclusion Criteria:

* active cervical infection
* current pregnancy
* prior pregnancy beyond 19 6/7 weeks
* uterine anomaly
* fibroid uterus distorting uterine cavity
* copper allergy or wilson's disease for ParaGard
* undiagnosed abnormal uterine bleeding
* cervical or uterine cancer
* sepsis associated with the most recent pregnancy
* current breast cancer for levonogestrel IUD
* inflammatory bowel disease
* allergy to misoprostol
C: Inclusion Criteria:

* 18 years old or older
* negative pregnancy test
* no prior pregnancies beyond 14 6/7 weeks
* no PID in last 3 months
* no current cervicitis
* be willing to follow-up in 1-2 months for an IUD string check.

Exclusion Criteria:

* active cervical infection
* current pregnancy
* prior pregnancy beyond 14 weeks gestation
* known uterine anomaly
* fibroid uterus distorting uterine cavity
* copper allergy/Wilson's disease (for Paragard)
* undiagnosed abnormal uterine bleeding
* cervical or uterine cancer.
D: Inclusion Criteria:

1. plans for IUD insertion for contraception or abnormal uterine bleeding;
2. 18 to 49 years of age;
3. reached more than 6 weeks postpartum or 2 weeks postabortion if recently pregnant;
4. no prior IUD use;
5. not taken analgesics or anxiolytics in the previous 24 hours;
6. not taken misoprostol prior to IUD insertion;
7. the ability and are willing to give informed consent;
8. speaks English or Spanish.

Exclusion Criteria:

1. any contraindication to IUD placement;
2. allergy to lidocaine or sensitivities to components of the lidocaine or placebo gel;
3. chronic narcotic/benzodiazepine/barbiturate use within the past year.

Answer: D