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Non-opioid Analgesic
Ketorolac + Lidocaine for Pain Relief During Hysteroscopy
Phase 1
Recruiting
Led By Charles Ascher-Walsh, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Chronic liver disease
History of gastritis or gastric ulcer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Summary
"This trial compared the pain relief effects of using a combination of ketorolac and lidocaine versus using just lidocaine during office hysteroscopies."
Who is the study for?
This trial is for individuals experiencing abnormal uterine bleeding who are undergoing office hysteroscopy, a procedure to look inside the uterus. Participants should meet certain health criteria not specified here.
What is being tested?
The study compares pain relief during hysteroscopy using two methods: one combines ketorolac (a pain reliever) with lidocaine (an anesthetic), and the other uses just lidocaine. It's a randomized trial, so participants are put into groups by chance.
What are the potential side effects?
Possible side effects may include discomfort at the injection site, allergic reactions to medications used, or inadequate pain control. Specific side effects of ketorolac can include stomach upset or bleeding.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a long-term liver condition.
Select...
I have had gastritis or a stomach ulcer in the past.
Select...
I have a history of unusual bleeding.
Select...
I have kidney problems.
Select...
I am allergic to ketorolac or NSAIDs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~with paracervical block, during procedure, immediately after procedure, thirty minutes after the procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Frequency of procedure termination
Pain visual analogue scale (VAS)
Patient Satisfaction
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lidocaine plus ketorolacExperimental Treatment3 Interventions
Paracervical block will be performed with lidocaine plus ketorolac
Group II: Lidocaine alonePlacebo Group2 Interventions
Paracervical block will be performed with just lidocaine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
2011
Completed Phase 4
~1370
ketorolac
2016
Completed Phase 4
~1270
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
903 Previous Clinical Trials
541,874 Total Patients Enrolled
1 Trials studying Paracervical Block
132 Patients Enrolled for Paracervical Block
Charles Ascher-Walsh, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
367 Total Patients Enrolled
1 Trials studying Paracervical Block
132 Patients Enrolled for Paracervical Block
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