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



Status:Completed
Conditions:Chronic Pain, Contraception, Contraception
Therapuetic Areas:Musculoskeletal, Reproductive
Healthy:No
Age Range:18 - Any
Updated:11/10/2018
Start Date:June 2014
End Date:December 2016

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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.

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
We found this trial at
1
site
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Principal Investigator: Shana M Miles, MD, PhD
Phone: 301-319-5027
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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mi
from
Bethesda, MD
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