Naproxen for Pain Control With Intrauterine Device Insertion
Completed · Not applicable · Has a placebo group
Conditions studied: Contraception
In brief
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.
Key facts
- Study ID
- NCT02388191
- Run by
- Planned Parenthood League of Massachusetts
- People needed
- 119
- Starts
- 2015-04-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2017-06-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Planned Parenthood League of Massachusetts — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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