NCT02769247

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

November 8, 2018

Completed
Last Updated

November 8, 2018

Status Verified

October 1, 2018

Enrollment Period

2.5 years

First QC Date

May 6, 2016

Results QC Date

June 21, 2018

Last Update Submit

October 10, 2018

Conditions

ContraceptionPain

Keywords

naproxenlidocaineintrauterine deviceIUDpain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Physician Perceived Pain Control During IUD Insertion

    within 30 minutes after IUD insertion

  • Patient Satisfaction With IUD

    30 days post insertion

  • Difficulty IUD Insertion

    within 30 minutes of IUD insertion

  • Perceived Pain 30 Days Post Insertion

    30 days post IUD insertion

Study Arms (4)

Placebo

EXPERIMENTAL

Patient will receive placebo oral medication and intrauterine normal saline prior to IUD insertion

Drug: placebo

Naproxen/Normal saline

EXPERIMENTAL

Patient will receive naproxen and intrauterine normal saline prior to IUD insertion

Drug: NaproxenDrug: placebo

Placebo oral medication/Lidocaine

EXPERIMENTAL

Patient will receive placebo oral medication and intrauterine lidocaine prior to IUD insertion

Drug: LidocaineDrug: placebo

Naproxen/Lidocaine

EXPERIMENTAL

Patient will receive naproxen and intrauterine lidocaine prior to IUD insertion

Drug: NaproxenDrug: Lidocaine

Interventions

NaproxenDRUG

Oral naproxen vs placebo

Naproxen/LidocaineNaproxen/Normal saline
LidocaineDRUG

Intrauterine lidocaine vs normal saline

Naproxen/LidocainePlacebo oral medication/Lidocaine
placeboDRUG

either normal saline or empty oral capsule

Naproxen/Normal salinePlaceboPlacebo oral medication/Lidocaine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DEERS-eligible reproductive age women (i.e. Tricare beneficiaries)
  • age 18 years and older
  • desiring Paragard or Mirena intrauterine device insertion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

  • 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.

    PMID: 31516731DERIVED

MeSH Terms

Conditions

Pain

Interventions

NaproxenLidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Limitations and Caveats

Sample size is limitation. Single site conducting study using single insurance payer.

Results Point of Contact

Title
Dr. Shana Miles
Organization
Walter Reed National Military Medical Center
shana.m.miles2.mil@mail.mil
318 456 6389

Study Officials

  • Susan Dunlow, MD

    WRNMMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 11, 2016

Study Start

June 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 8, 2018

Results First Posted

November 8, 2018

Record last verified: 2018-10

Locations

US(1)