Intrauterine Device Insertion Pain Management

University of Missouri (MU)

Status and phase: Not yet enrolling; Phase 4

Conditions: IUD Insertion; IUD Insertion Pain

Treatments: Drug: Saline 0.9%; Drug: Lidocaine 2%; Other: Sham injection; Drug: Benzocaine 20%

Study type: Interventional

Funder types: Other

Identifiers

NCT06951191

2101465

Details and patient eligibility

About

The goal of this clinical trial is to learn if use of topical benzocaine prior to the injection of lidocaine is effective in decreasing pain experienced during IUD insertion in patients 18 or older. The main question it aims to answer is:

Does topical use of benzocaine prior to lidocaine injection during IUD insertion effectively decrease pain experienced?

Researchers will compare benzocaine/lidocaine to benzocaine/placebo, placebo/lidocaine, and placebo/placebo to see if use of benzocaine prior to lidocaine injection works more effectively to decrease pain experienced rather than lidocaine, benzocaine, or placebo use alone.

Participants will:

• Arrive to clinic for previously scheduled IUD insertion
• Be screened, approached by research staff, and consented to join the trial
• Complete a demographic questionnaire
• Be randomly and blindly assigned to one of four groups
• Placebo/Placebo
• Placebo/Lidocaine
• Benzocaine/Placebo
• Benzocaine/Lidocaine
• All groups will be given 600mg of ibuprofen prior to procedure
• Be asked to rate their pain on a visual scale of 1-10 during several distinct points of the procedure.
• Be sent an optional survey to their email after the procedure

Full description

The goal of the researchers is to determine if use of a topical benzocaine spray prior to lidocaine injection will cause a significant reduction in pain experienced by patients undergoing an IUD insertion. Participants will be screened, approached, and fully consented by research staff in the clinic prior to their IUD insertion. Demographics will be gathered from all participants through a questionnaire. All participants will be given 600mg of ibuprofen prior to the procedure, but will be randomized into one of 4 groups as to what interventions/placebos they will receive during their insertion. Interventions studied are benzocaine spray and lidocaine injection. Placebos will be saline spray and paracervical needle stick without injection. Participants will be asked to rate their pain on a visual scale of 1-10 at the following timepoints during the procedure:

• At the time of tenaculum placement
• At the time of uterine sounding
• At the time of IUD insertion and deployment
• Immediately after removal of instrumentation
• 15 minutes after the procedure Participants who provided an email will be sent an additional questionnaire to be responded to within 24 hours of the procedure. At the conclusion of the trial statistical analysis will be done to determine significance of pain reduction varying between the 4 groups.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Undergoing IUD insertion

Exclusion criteria

• IUD insertion <6 weeks postpartum
• Age <18 years
• Allergy or history of adverse effect of lidocaine, benzocaine (and inactive ingredients: flavor, isobutane, propane, polyethylene glycol, sodium saccharin), or ibuprofen
• Not undergoing IUD insertion
• Undergoing IUD insertion under general anesthesia
• Usage of anti-inflammatory or as-needed anxiety medications (not daily use) in the 12 hours prior to IUD insertion

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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160 participants in 4 patient groups, including a placebo group

Placebo/Placebo

Placebo Comparator group

Description:

Participants in this arm will receive saline spray and a needle stick without injection to the cervix

Treatment:

Other: Sham injection

Drug: Saline 0.9%

Placebo/Lidocaine

Experimental group

Description:

Participants in this arm will receive saline spray and injected lidocaine to the cervix

Treatment:

Drug: Lidocaine 2%

Drug: Saline 0.9%

Benzocaine/Placebo

Experimental group

Description:

Participants in this arm will receive benzocaine spray and a needle stick without injection to the cervix

Treatment:

Drug: Benzocaine 20%

Other: Sham injection

Benzocaine/Lidocaine

Experimental group

Description:

Participants in this arm will receive benzocaine spray and lidocaine injection to the cervix

Treatment:

Drug: Benzocaine 20%

Drug: Lidocaine 2%