Naproxen for Pain Control With Intrauterine Device Insertion
- Conditions
- Contraception
- Interventions
- Drug: Naproxen sodiumOther: Placebo tablet
- Registration Number
- NCT02388191
- Lead Sponsor
- Planned Parenthood League of Massachusetts
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 119
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Naproxen sodium Naproxen sodium 550 mg naproxen sodium Placebo Placebo tablet Placebo
- Primary Outcome Measures
Name Time Method Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS) Immediately after IUD insertion is complete Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
- Secondary Outcome Measures
Name Time Method Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS) Immediately after tenaculum is placed on cervix Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) Fifteen minutes after IUD insertion is complete Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS) Immediately after uterine sounding Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) Five minutes after IUD insertion is complete Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Trial Locations
- Locations (1)
Planned Parenthood League of Massachusetts
🇺🇸Boston, Massachusetts, United States