Efficacy of Intrauterine Lidocaine and Naproxen for Pain Control With Intrauterine Device Insertion
NCT ID: NCT02769247
Last Updated: 2018-11-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2014-06-30
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion
placebo
either normal saline or empty oral capsule
Naproxen/Normal saline
Patient will receive naproxen and intrauterine normal saline prior to IUD insertion
Naproxen
Oral naproxen vs placebo
placebo
either normal saline or empty oral capsule
Placebo oral medication/Lidocaine
Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion
Lidocaine
Intrauterine lidocaine vs normal saline
placebo
either normal saline or empty oral capsule
Naproxen/Lidocaine
Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion
Naproxen
Oral naproxen vs placebo
Lidocaine
Intrauterine lidocaine vs normal saline
Interventions
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Naproxen
Oral naproxen vs placebo
Lidocaine
Intrauterine lidocaine vs normal saline
placebo
either normal saline or empty oral capsule
Eligibility Criteria
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Inclusion Criteria
* age 18 years and older
* desiring Paragard or Mirena intrauterine device insertion
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Walter Reed National Military Medical Center
FED
Responsible Party
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Principal Investigators
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Susan Dunlow, MD
Role: PRINCIPAL_INVESTIGATOR
WRNMMC
Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Countries
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References
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Miles SM, Shvartsman K, Dunlow S. Intrauterine lidocaine and naproxen for analgesia during intrauterine device insertion: randomized controlled trial. Contracept Reprod Med. 2019 Sep 10;4:13. doi: 10.1186/s40834-019-0094-0. eCollection 2019.
Other Identifiers
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384645-5
Identifier Type: -
Identifier Source: org_study_id
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