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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769247
• Other study ID #: 384645-5
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2018
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Pain

Intervention

Drug:
• Naproxen
Oral naproxen vs placebo
• Lidocaine
Intrauterine lidocaine vs normal saline
• placebo
either normal saline or empty oral capsule

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 30 minutes after IUD insertion
Secondary	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	within 30 minutes after IUD insertion
Secondary	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.	30 days post insertion
Secondary	Difficulty IUD Insertion	as rated by the physician. Very easy/easy were rated as "easy" whereas difficult/very difficult is difficult.	within 30 minutes of IUD insertion
Secondary	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).	30 days post IUD insertion