Naproxen for Pain Control With Intrauterine Device Insertion

Study Overview
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Brief Summary
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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.

Official Title
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Naproxen for Pain Control With Intrauterine Device Insertion: A Randomized Double-Blind Placebo Controlled Trial

Conditions
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Contraception

Intervention / Treatment
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* Drug: Naproxen sodium
* Other: Placebo tablet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naproxen sodium<br>550 mg naproxen sodium | Drug: Naproxen sodium<br>* 550 mg, oral, on day 1. Number of Cycles: 1<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo tablet<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after IUD insertion is complete | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Fifteen minutes after IUD insertion is complete | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Naproxen, Intrauterine devices, Pain Control