Naproxen for Pain Control With Intrauterine Device Insertion
| Status: | Recruiting |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| End Date: | April 2016 |
| Contact: | Principal Investigator, MD, MPH |
| Phone: | 617.616.1600 |
Naproxen for Pain Control With Intrauterine Device Insertion: A Randomized Double-Blind Placebo Controlled Trial
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.
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.
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)
We found this trial at
1
site
Boston, Massachusetts 02215
Principal Investigator: Principal Investigator, MD, MPH
Phone: 617-616-1600
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