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NCT06853327

Oral Ketorolac for IUD Pain Reduction

Enrolling by Invitation
PHASE2Ages 18+InterventionalTreatment
University of North Carolina, Chapel Hill
~108 participants
Updated 2025-05-30 on ClinicalTrials.gov
What's tested:KetorolacPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion
Measured over All 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

Conditions

IUD Insertion Pain

Explore related trials

IUD Insertion Pain

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Amy G Bryant, M.D. · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

18 years or older
Able to consent
Desires IUD insertion

Exclusion

IUD placement under sedation or oral anxiolytic
IUD replacement (removal with insertion)
Daily narcotic or NSAID use
Contraindications to IUD placement
Current: pregnancy, genital/pelvic infection
Lifetime history: uterine anomaly, pelvic inflammatory disease, allergy to levonorgestrel or copper
Contraindications to ketorolac
Current: weight under 50 kilograms
Lifetime history: allergy to NSAIDs, liver disease, renal disease, peptic ulcer disease, cerebrovascular bleeding, gastrointestinal bleeding

What this trial measures

  • Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertionAll 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

    To compare the mean VAS pain scores between study arms (K2 vs K1 vs K0) at each timepoint during and after IUD insertion (pre-procedure, tenaculum placement, PCB injection, uterine sounding, IUD deployment, overall (measured immediately post-procedure), and 10 minutes post-procedure). To assess VAS scores, a 100mm ruler will be presented to the patient at the listed timepoints. The patient will adjust a slider on the ruler to correspond to their pain level, with 0mm representing no pain and 100mm representing worst possible pain. The VAS scores will be reported as means and compared via repeated measure ANOVA test yielding confidence intervals and p-values and to assess for significance.