Clinical Trial

Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement

Unknown Phase 4
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Record status
This record was last updated July 31, 2024 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.
Summary
Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement. Propofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement.. The current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT05875571
Lead Sponsor Arkansas Children's Hospital Research Institute
Conditions IUD, Healthy Female, Contraception, IUD Insertion Complication
Enrollment 18 participants
Start Date 2024-02-05
Primary Completion 2025-05 (estimated)
Study Completion 2025-06 (estimated)
Updated on ClinicalTrials.gov 2024-07-31