N/A
N=160
Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion
Contraception · Pain
Bottom Line
View on ClinicalTrials.gov: NCT02769247 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Pain Control With IUD Insertion — 3.606; 3.088; 2.83; 3.382 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Naproxen (Drug); Lidocaine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Walter Reed National Military Medical Center
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Control With IUD Insertion |
3.606; 3.088; 2.83; 3.382 | — |
| SECONDARY Physician Perceived Pain Control During IUD Insertion |
.59; .48; .56; .77 | — |
| SECONDARY Patient Satisfaction With IUD |
4.423; 4.325; 4.264; 4.358 | — |
| SECONDARY Difficulty IUD Insertion |
36; 38; 38; 38; 2; 2 | — |
| SECONDARY Perceived Pain 30 Days Post Insertion |
3.12; 2.97; 3.2; 3.04 | — |
Summary
To compare the efficacy of intrauterine lidocaine and oral naproxen sodium on discomfort and pain of patients undergoing intrauterine device insertion.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02769247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.