Naproxen for Pain Control With Intrauterine Device Insertion

Planned Parenthood League of Massachusetts

Status

Completed

Conditions

Contraception

Treatments

Drug: Naproxen sodium

Other: Placebo tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT02388191

2015P000436

Details and patient eligibility

About

The purpose of this study is:

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).
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).
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.

Enrollment

119 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)