← Back to Search

Topical Analgesia for IUD Insertion Comfort (PAP-AID Trial)

Phase 4

Waitlist Available

Led By Michael J Arnold, MD

Research Sponsored by Uniformed Services University of the Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up obtained immediately after the procedure prior to the patient leaving the clinic

Awards & highlights

PAP-AID Trial Summary

This trial will study if using a local anesthetic on a tampon helps reduce pain and make IUD insertion faster and easier for patients.

Who is the study for?

This trial is for individuals aged 18 or older who want an intrauterine device (IUD) inserted and are willing to return after giving virtual consent. It's not specified who can't join, but typically those with allergies to the medication used or other health issues might be excluded.Check my eligibility

What is being tested?

The study tests if a tampon soaked in lidocaine (a numbing agent) applied by patients themselves before IUD insertion helps reduce pain and procedure time compared to a saline solution. The effectiveness will be measured through patient feedback and procedural metrics.See study design

What are the potential side effects?

Lidocaine may cause local reactions like tingling, burning, or itching at the application site. Systemic side effects are rare when used topically but could include symptoms such as dizziness or allergic reactions.

PAP-AID Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ obtained immediately after the procedure prior to the patient leaving the clinic

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~obtained immediately after the procedure prior to the patient leaving the clinic

This trial's timeline: 3 weeks for screening, Varies for treatment, and obtained immediately after the procedure prior to the patient leaving the clinic for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient-reported pain level

Procedure time

Secondary outcome measures

Patient-reported interest in subsequent procedure

Patient-reported satisfaction with procedure

Provider-reported procedural difficulty

PAP-AID Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Aqueous lidocaineExperimental Treatment2 Interventions

Subject issued 5 ml jar of aqueous 4% lidocaine and will dip tampon distal end into jar for 30 seconds prior to placement.

Group II: SalinePlacebo Group1 Intervention

Subject issued 5 ml jar of sterile saline and will dip tampon distal end into jar for 30 seconds prior to placement.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lidocaine topical

2018

Completed Phase 4

~320

Tampon

2020

Completed Phase 1

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Uniformed Services University of the Health SciencesLead Sponsor

116 Previous Clinical Trials

91,296 Total Patients Enrolled

American Academy of Family Physicians National Research NetworkNETWORK

7 Previous Clinical Trials

63,869 Total Patients Enrolled

Michael J Arnold, MDPrincipal InvestigatorAssociate Professor, Uniformed Services University of the Health Sciences

Media Library

Aqueous lidocaine Clinical Trial Eligibility Overview. Trial Name: NCT05890495 — Phase 4

Birth Control Research Study Groups: Saline, Aqueous lidocaine

Birth Control Clinical Trial 2023: Aqueous lidocaine Highlights & Side Effects. Trial Name: NCT05890495 — Phase 4

Aqueous lidocaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05890495 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be satisfied for potential participants to qualify for this investigation?

"To participate in this research, candidates must be between 18-54 years of age and on some form of birth control. A total of 120 people are required for the trial to reach completion."

Answered by AI

What potential health risks does the administration of aqueous lidocaine entail?

"Taking into account the Phase 4 status of this treatment, our team at Power has judged aqueous lidocaine to be safe and assigned it a score of 3."

Answered by AI

Is there an age restriction for participation in this medical experiment?

"The study participants must be between 18 and 54 years old in order to meet the eligibility criteria. Separate studies are available for individuals under 18 and older than 65."

Answered by AI

Are there vacancies available for participants to join this research trial?

"The information on clinicaltrials.gov reveals that this particular trial is not actively recruiting patients. This medical study, which was initially uploaded to the website on June 1st 2023, has been revised most recently on May 25th 2023; however, there are 55 other trials in need of participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement

Mike Arnold 2023. "Patient-Applied Pretreatment Analgesia for Intrauterine Device Placement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05890495.