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Nonsteroidal Anti-Inflammatory Drug

Ketorolac for IUD Pain

Hillsborough, NC
Phase 2
Waitlist Available
Led By Amy G Bryant, M.D.
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
Be older than 18 years old
Must not have
IUD placement under sedation or oral anxiolytic
Daily narcotic or NSAID use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up parity is recorded during intake 1 week prior to iud. vas pain scores will be measured during their iud appointment. 5 timepoints will be measured during iud insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards

Summary

This trial aims to see if taking a painkiller, ketorolac, at different times before getting an IUD inserted affects the amount of pain felt during the procedure. This trial is trying

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Who is the study for?
This trial is for individuals who are 18 years or older, can give consent, and want an IUD inserted. It's not for those sedated during IUD placement, replacing an IUD, pregnant, with current infections or certain medical histories like uterine anomalies or allergies to IUD materials.Check my eligibility
What is being tested?
The study tests if taking oral ketorolac (a pain reliever) at different times before getting an IUD affects the pain felt during the procedure. Participants will either receive ketorolac or a placebo without knowing which one they get.See study design
What are the potential side effects?
Ketorolac may cause side effects such as stomach upset, bleeding issues, and allergic reactions in some people. The exact side effects experienced by participants in this trial will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had an IUD placed with sedation or anxiety medication.
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I use painkillers or anti-inflammatory drugs daily.
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I am not pregnant and do not have a genital or pelvic infection.
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I weigh less than 50 kilograms.
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I cannot take ketorolac due to health reasons.
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I have never had an allergy to NSAIDs, liver, kidney, stomach ulcers, or any bleeding in the brain or gut.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~parity is recorded during intake 1 week prior to iud. vas pain scores will be measured during their iud appointment. 5 timepoints will be measured during iud insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards
This trial's timeline: 3 weeks for screening, Varies for treatment, and parity is recorded during intake 1 week prior to iud. vas pain scores will be measured during their iud appointment. 5 timepoints will be measured during iud insertion (~10 total minutes), 1 immediately after the procedure, 1 ten minutes afterwards for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion
Secondary study objectives
Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion, controlling for parity
Difference in rate of "severe pain" (VAS pain scores 70-100mm) between study arms at 7 timepoints during and after IUD insertion
Difference in rate of acceptable pain levels between study arms at 7 timepoints during and after IUD insertion
+1 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: K2 - Ketorolac 2-hourActive Control2 Interventions
Receives Ketorolac 20mg PO at 2 hours prior and placebo at 1 hour prior to IUD
Group II: K1 - Ketorolac 1-hourActive Control2 Interventions
Receives placebo at 2 hours and Ketorolac 20mg PO at 1 hour prior to IUD
Group III: K0 - Placebo controlPlacebo Group1 Intervention
Receives placebo at 2 hours and at 1 hour prior to IUD

Find a Location

Closest Location:University of North Carolina - Hillsborough Campus· Hillsborough, NC· 343 miles

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,585 Previous Clinical Trials
4,363,739 Total Patients Enrolled
Amy G Bryant, M.D.Principal InvestigatorUniversity of North Carolina, Chapel Hill
~72 spots leftby Jun 2026