Naproxen for Pain Control With Intrauterine Device Insertion

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Naproxen sodium

550 mg naproxen sodium

Group Type EXPERIMENTAL

Naproxen sodium

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type OTHER

Interventions

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Naproxen sodium

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

Intervention Type DRUG

Placebo tablet

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes