Ketorolac + Lidocaine for Pain Management
(PCB-KinD 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?
Sadia MA Haider, MD, MPH
Principal Investigator
Rush University Medical Center
Kathryn Crofton, MD
Principal Investigator
Rush University Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a paracervical block with combined ketorolac and lidocaine or standard treatment with oral ibuprofen and lidocaine paracervical block
Follow-up
Participants are monitored for pain management effectiveness and satisfaction over 24 hours post-dilator insertion
What Are the Treatments Tested in This Trial?
Interventions
- Ketorolac
- Lidocaine
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Oral placebo and Paracervical Block with combined 1% Lidocaine and Ketorolac
Oral ibuprofen with plain 1% lidocaine paracervical block
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
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