MedPath

Naproxen for Pain Control With Intrauterine Device Insertion

Not Applicable
Completed
Conditions
Contraception
Interventions
Drug: Naproxen sodium
Other: 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
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
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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)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Naproxen sodiumNaproxen sodium550 mg naproxen sodium
PlaceboPlacebo tabletPlacebo
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

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