Clinical trial NCT02388191: Naproxen for Pain Control With Intrauterine Device Insertion
Official title: Naproxen for Pain Control With Intrauterine Device Insertion: A Randomized Double-Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Contraception
Naproxen
Intrauterine devices
Pain Control
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 119
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility 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)

Primary outcomes:
measure: Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)
timeFrame: Immediately after IUD insertion is complete
Secondary outcomes:
measure: Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)
timeFrame: Immediately after tenaculum is placed on cervix
measure: Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)
timeFrame: Immediately after uterine sounding
measure: Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
timeFrame: Five minutes after IUD insertion is complete
measure: Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
timeFrame: Fifteen minutes after IUD insertion is complete
Other outcomes:
Locations:
city: Boston
country: United States
facility: Planned Parenthood League of Massachusetts
state: Massachusetts
Study officials:
affiliation: PPLM
name: Principal Investigator, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngo LL, Braaten KP, Eichen E, Fortin J, Maurer R, Goldberg AB. Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1306-1313. doi: 10.1097/AOG.0000000000001746.