Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion

Walter Reed National Military Medical Center

Status: Completed

Conditions: Contraception; Pain

Treatments: Drug: Lidocaine; Drug: Naproxen; Drug: placebo

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02769247

384645-5

Details and patient eligibility

About

To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.

Full description

This is a randomized, double-blind, placebo-controlled study with women that will be recruited from our outpatient obstetrics and gynecology clinic. Women desiring intrauterine device insertion will be invited to participate.

The investigators plan to recruit women desiring intrauterine device insertion into one of four groups: A: placebo/normal saline infusion; B: placebo/lidocaine infusion; C: Saline infusion/ naproxen; D: lidocaine infusion/ naproxen.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• DEERS-eligible reproductive age women (i.e. Tricare beneficiaries)
• age 18 years and older
• desiring Paragard or Mirena intrauterine device insertion

Exclusion criteria

• Current pregnancy
• cervical stenosis
• severe medical illness
• known allergy or sensitivity to lidocaine or naproxen
• peptic ulcer disease
• current pelvic inflammatory disease
• patients with known renal insufficiency
• patients using chronic NSAIDs or on chronic pain medication
• women desiring Skyla IUD insertion will also be excluded due to infrequency of insertions at WRNMMC

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 4 patient groups

Placebo

Experimental group

Description:

Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion

Treatment:

Drug: placebo

Naproxen/Normal saline

Experimental group

Description:

Patient will receive naproxen and intrauterine normal saline prior to IUD insertion

Treatment:

Drug: placebo

Drug: Naproxen

Placebo oral medication/Lidocaine

Experimental group

Description:

Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion

Treatment:

Drug: placebo

Drug: Lidocaine

Naproxen/Lidocaine

Experimental group

Description:

Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion

Treatment:

Drug: Naproxen

Drug: Lidocaine