Ketorolac + Lidocaine for Pain Management

(PCB-KinD Trial)

CM
Overseen ByCristina MA Barkowski, MSW, DrPH(s)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to improve pain management for participantswho need osmotic dilators for cervical preparation the day before their second trimester abortion procedure. Osmotic dilators are sticks that are inserted into the cervix. They soak up fluid and expand overnight, gently opening the cervix. We are studying an injection of ketorolac (a liquid anti-inflammatory medication similar to ibuprofen) combined with lidocaine (a liquid numbing medication), which is injected vaginally to the area surrounding the cervix. Ketorolac is approved by the U.S. Food and Drug Administration (FDA) for intravenous (IV) and intramuscular injection and has been studied as a paracervical injection for participants having first trimester abortion procedures in the office. It has not previously been studied for osmotic dilator insertion.

Who Is on the Research Team?

SM

Sadia MA Haider, MD, MPH

Principal Investigator

Rush University Medical Center

KC

Kathryn Crofton, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I need an osmotic dilator placed the day before my abortion procedure.
I am at least 18 years old.
I can speak English or Spanish.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a paracervical block with combined ketorolac and lidocaine or standard treatment with oral ibuprofen and lidocaine paracervical block

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain management effectiveness and satisfaction over 24 hours post-dilator insertion

24 hours
1 follow-up contact (virtual or phone)

What Are the Treatments Tested in This Trial?

Interventions

  • Ketorolac
  • Lidocaine

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Treatment GroupExperimental Treatment3 Interventions
Group II: Standard TreatmentActive Control3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials
448
Recruited
247,000+