Naproxen for Pain Control With Intrauterine Device Insertion

Planned Parenthood League of Massachusetts119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

119

Conditions

Contraception

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)

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.

Time frame: Immediately after IUD insertion is complete

Secondary Outcomes

Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)

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.

Time frame: Immediately after tenaculum is placed on cervix

Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)

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.

Time frame: Immediately after uterine sounding

Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)

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.

Time frame: Five minutes after IUD insertion is complete

Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)

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.

Time frame: Fifteen minutes after IUD insertion is complete