Oral Ketorolac for IUD Pain Reduction

Part of paid clinical trials in Hillsborough, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06853327
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • IUD Insertion Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ketorolac — DRUG
    The experimental condition to be examined by this study is the timing of administration of ketorolac prior to IUD insertion. Ketorolac 20mg PO has proven beneficial at certain timepoints during IUD insertion in prior studies, but pharmacokinetics indicate that it could require more time until peak analgesia.
  • Placebo — DRUG
    Placebo will be used to control the timing of administration and be used to compare ketorolac to baseline standard pain control regimens

Study Details

To determine if oral ketorolac given at different timepoints prior to intrauterine device (IUD) insertion influences pain experienced during this procedure.

Key Dates

Start date
May 23, 2025
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: K2 - Ketorolac 2-hour
    Receives Ketorolac 20mg PO at 2 hours prior and placebo at 1 hour prior to IUD
  • Active Comparator: K1 - Ketorolac 1-hour
    Receives placebo at 2 hours and Ketorolac 20mg PO at 1 hour prior to IUD
  • Placebo Comparator: K0 - Placebo control
    Receives placebo at 2 hours and at 1 hour prior to IUD

Primary Outcome Measure

Difference in mean VAS pain scores between study arms at 7 timepoints during and after IUD insertion [ Time Frame: 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina - Hillsborough CampusHillsboroughNorth Carolina27278-

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