Using Ketorolac to Reduce Pain During IUD Insertion
Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement: A Randomized, Double-Blind, Placebo-Controlled Trial
This study is testing if giving ketorolac can help reduce pain for young women during and after IUD insertion compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 13 Years to 21 Years |
| Sex | Female |
| Sponsor | Arkansas Children's Hospital Research Institute Academic / other |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT05875571 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of ketorolac, a nonsteroidal anti-inflammatory drug, in reducing pain during and after the insertion of intrauterine devices (IUDs) in adolescents. Participants will receive either ketorolac or a placebo alongside propofol, which is used for sedation during the procedure. The goal is to compare pain levels and overall comfort between the two groups to determine if ketorolac can enhance the IUD insertion experience. This research addresses a significant barrier to IUD use among young women, aiming to improve their access to effective contraception.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents requiring sedated IUD placement at Arkansas Children's Hospital.
Not a fit: Patients with allergies to ketorolac or other NSAIDs, renal impairment, or a history of GI bleeding or peptic ulcer disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve comfort and satisfaction for adolescents undergoing IUD placement.
How similar studies have performed: Previous studies have explored various methods to reduce pain during IUD insertion, but the specific use of ketorolac in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients requiring sedated IUD placement at Arkansas Children's Hospital Exclusion Criteria: * Allergy to ketorolac or other NDSAID * Known history of renal impairment * History of GI bleeding of peptic ulcer disease
Where this trial is running
Little Rock, Arkansas
- Arkansas Childrens Hospital — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Study coordinator: Shahwar Yousuf, MD
- Email: syousuf@uams.edu
- Phone: 501-364-1341
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.