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

Walter Reed National Military Medical Center logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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