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

Walter Reed National Military Medical Center160 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Contraception Pain

Interventions

NaproxenDRUG

Oral naproxen vs placebo

LidocaineDRUG

Intrauterine lidocaine vs normal saline

placeboDRUG

either normal saline or empty oral capsule

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Outcomes

Primary Outcomes

Pain Control With IUD Insertion

visual analog scale (0-10) as assessed by patient within 30 minutes after IUD insertion. Scale is from a minimum of 0, with maximum of 10 with higher scores denoting more pain

Time frame: within 30 minutes after IUD insertion

Secondary Outcomes

Physician Perceived Pain Control During IUD Insertion

visual analog scale (0-3) as assessed by physician within 30 minutes after IUD insertion Scale is from a minimum of 0, with maximum of 3 with higher scores denoting more pain

Time frame: within 30 minutes after IUD insertion

Patient Satisfaction With IUD

Patient satisfaction as rated on a 1-5 scale 30 days post insertion. Scale of 5 means highly satisfied, 1 means unsatisfied.

Time frame: 30 days post insertion

Difficulty IUD Insertion

as rated by the physician. Very easy/easy were rated as "easy" whereas difficult/very difficult is difficult.

Time frame: within 30 minutes of IUD insertion

Perceived Pain 30 Days Post Insertion

survey patient 30 days later to determine her recollection of pain during insertion (0-10); 10 being the most pain. One patient had no IUD initially inserted and was not included; each arm had patients lost to follow up (3 in placebo arm, 2 in naproxen arm, 4 in placebo/oral medication arm).

Time frame: 30 days post IUD insertion

Data from ClinicalTrials.gov

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