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NCT05875571 · ClinicalTrials.gov registry record · Phase 4
Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement
A Phase 4 study of Contraception and IUD, sponsored by Arkansas Children's Hospital Research Institute.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT05875571: Recruiting Phase 4 study of Contraception and IUD, sponsored by Arkansas Children's Hospital Research Institute.
NCT05875571 is a Phase 4 study of Contraception and IUD that is actively recruiting participants, run by Arkansas Children's Hospital Research Institute. The registered enrollment target is 18 participants, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05875571, a Phase 4 study of Contraception and IUD, is actively recruiting participants, sponsored by Arkansas Children's Hospital Research Institute.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ketorolac
Study Locations (1)
Arkansas
- Arkansas Childrens Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-02-05 |
| Est. Completion | 2025-06 |
| Phase | Phase 4 |
What NCT05875571 shows while recruiting
NCT05875571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Contraception appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05875571 reports a single indexed study location in Arkansas.
Frequently Asked Questions
What is clinical trial NCT05875571 about?
NCT05875571 is a clinical study titled "Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement". 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 adolescen...
What is the current status of trial NCT05875571?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2024-02-05. Estimated completion is 2025-06.
What conditions does trial NCT05875571 study?
This clinical trial studies the following conditions: Contraception, IUD, Healthy Female, IUD Insertion Complication.
What interventions are being tested in trial NCT05875571?
The interventions under investigation include: Placebo (DRUG), Ketorolac (DRUG).
Who is sponsoring clinical trial NCT05875571?
This trial is sponsored by Arkansas Children's Hospital Research Institute, which has 97 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05875571 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05875571's enrollment target sits among peer trials
18 63rd of 72 higher than 9 of 72 other Contraception trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraception trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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