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Completed

NCT Number: NCT02388191

Naproxen for Pain Control With Intrauterine Device Insertion

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.

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Key information

Conditions

Contraception Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood League of Massachusetts

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Naproxen sodium

Drug

550 mg, oral, on day 1. Number of Cycles: 1

Placebo tablet

Other

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Planned Parenthood League of Massachusetts

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2015
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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