76 Participants NeededMy employer runs this trial

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?

This trial aims to improve pain management for those needing osmotic dilators before a second-trimester abortion. It will test a mix of ketorolac (an anti-inflammatory similar to ibuprofen) and lidocaine (a numbing medicine) injected around the cervix. The trial includes two groups: one receiving the new injection and a placebo pill, and the other receiving standard treatment with ibuprofen and lidocaine. Candidates may be suitable if they seek an outpatient abortion at Rush University Medical Center and require osmotic dilators placed the day before the procedure.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to advancing pain management options.

Will I have to stop taking my current medications?

The trial requires that you have not taken NSAIDs (like ibuprofen) less than 6 hours before your clinic visit. If you are currently using narcotics or recreational drugs (except cannabis), you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using ketorolac and lidocaine together is generally safe and effective for pain relief. In studies, patients who received this combination reported significantly lower pain levels compared to those who only received lidocaine. This suggests that the combination is both effective and safe.

The FDA has already approved ketorolac for injections, such as those administered into a vein or muscle, which reassures its safety in various forms. Additionally, research has found that patients typically respond well to the ketorolac-lidocaine mix, with no major safety issues reported. Overall, the evidence supports the safe use of this combination for managing pain.12345

Why do researchers think this study treatment might be promising for pain management?

Researchers are excited about the combination of Ketorolac and Lidocaine for pain management because it offers a novel approach to blocking pain. Unlike standard treatments like ibuprofen with lidocaine, this combination uses Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), to potentially enhance pain relief when used with Lidocaine. This method could provide more effective pain management without relying solely on oral medications, promising quicker and potentially stronger relief.

What evidence suggests that this treatment might be an effective treatment for pain management?

Research has shown that combining ketorolac with lidocaine for pain relief is more effective than using lidocaine alone. In this trial, participants in the intervention treatment group will receive a paracervical block with a combination of 1% lidocaine and ketorolac. Studies have found that this combination significantly reduces pain within the first 24 hours after procedures. Specifically, patients who received both ketorolac and lidocaine reported less pain compared to those who only received lidocaine. This combination not only alleviates immediate pain but also enhances comfort during recovery. These findings suggest that using ketorolac with lidocaine could be a promising approach to managing pain from osmotic dilator insertion.23678

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?

This trial is for adults (18+) who are seeking an outpatient second trimester abortion at Rush University Medical Center and need osmotic dilators placed the day before their procedure. Participants must be able to speak English or Spanish, have a single pregnancy between 16 and 24 weeks, and agree to study requirements.

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

Trial Overview

The study compares pain relief methods during cervical preparation: one group receives a vaginal injection of ketorolac (an anti-inflammatory) plus lidocaine (a numbing medicine), while others may receive ibuprofen by mouth, saline, or placebo. The goal is to see if the injection better manages pain from dilator placement.

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33607813/

Ketorolac plus Lidocaine vs Lidocaine for pain relief ...

Local injection of Lidocaine - Ketorolac combination had a superior pain-controlling effect during the first 24 hours after the biopsy procedure.

Ketorolac plus Lidocaine vs Lidocaine for pain relief following

Local injection of 30 mg Ketorolac in combination with Lidocaine resulted in improved pain control compared to Lidocaine alone for up to 24 ...

Analgesic effect of ketorolac added to lidocaine in surgery of ...

In summary, ketorolac reduces the intensity of postoperative pain both during the time spent in the recovery room and during the transfer to the hospital ward, ...

iv-lidocain-ketorolac-for-renal-colic. ...

Secondary outcome measures: o At 30 minutes, the combination group had improved from 8.40 mean pain score at baseline to. 3.14 (difference = ...

Intravenous use of lidocaine, magnessium, ketorolac as a ...

Our results showed that 80% (12/15) patients who received the MLK solution showed a significant and adequate pain relief to cross over from severe >7/10 pain to ...

Ketorolac plus Lidocaine vs Lidocaine for pain relief following ...

Patients receiving Lidocaine – Ketorolac combination dosage had significantly lower VAS scores, and these results confirm that local injection of Lidocaine – ...

Comparing postoperative pain relief: ketorolac and ... - PMC

The findings suggest that both lidocaine and ketorolac are effective in pain management, with ketorolac demonstrating superior pain reduction.

Evidence‐based safety profile of oral ketorolac in adults ...

In summary, multiple intakes of oral ketorolac significantly reduce the risk of any adverse event by 21.99% in a range of 34.63% to 6.9% when ...