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 — DRUGThe 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 — DRUGPlacebo 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-hourReceives Ketorolac 20mg PO at 2 hours prior and placebo at 1 hour prior to IUD
- Active Comparator: K1 - Ketorolac 1-hourReceives placebo at 2 hours and Ketorolac 20mg PO at 1 hour prior to IUD
- Placebo Comparator: K0 - Placebo controlReceives 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of North Carolina - Hillsborough Campus | Hillsborough | North Carolina | 27278 | - |
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