Naproxen for Pain Control With Intrauterine Device Insertion

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is:

1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome).

2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes).

3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion.

Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Planned Parenthood League of Massachusetts
• Treatments: Naproxen

Criteria

Inclusion Criteria:

• Age 18 years or older

• Premenopausal

• Presenting for insertion of any IUD type (i.e. Mirena, Paragard, Skyla)

• English-speaking or non-English speaking with appropriate translator available

Exclusion Criteria:

• Currently pregnant or pregnant within the last 4 weeks

• Not eligible for IUD insertion per PPLM's clinical protocols

• Presenting for IUD removal and reinsertion

• Any diagnosis of chronic pain (including fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)

• Pain medications taken within 12 hours of enrollment

• Misoprostol usage within 24 hours of enrollment

• Any known allergy or contraindication to non-steroidal anti-inflammatory drugs (including active renal disease, active hepatic disease, gastric ulcer disease or gastritis, and bleeding disorders)