NCT03031795

Oral Ketorolac for Pain Relief During IUD Insertion

Oral Ketorolac for Pain Relief During IUD Insertion: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: OhioHealth · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after surgical procedures. When taken orally, it should not cause sedation. The purpose of this study is to determine if oral ketorolac is effective at reducing pain during IUD placement versus a placebo tablet.

Detailed description

In the United States, 10% of women choose an intrauterine device (IUD) for contraception. With typical use, unintended pregnancy rates in the first year of IUD contraception are 0.8% (Copper T) and 0.2% (LNG). It is known that long-acting, reversible contraception methods reduce the long-term cost of unintended pregnancies. A common deterrent to intrauterine contraception is the fear of pain during placement. Methods of pain relief during IUD insertion must be fast-acting but have minimal sedation. There have been many attempts to find effective pain relief during IUD placement. Neither ibuprofen nor naproxen have been shown to be effective in reducing pain. Misoprostol has been used to increase cervical ripening; however, pain was not decreased, and side effects of nausea and vomiting were increased. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that works by reversibly inhibiting cyclooxygenase-1 and 2.Time to peak plasma concentration ketorolac in the oral form is 44 minutes. Studies have shown that one dose of ketorolac can be as potent as morphine. Ketorolac is also well established for pain control in the immediate post-operative period. A recent study showed that intramuscular ketorolac wais effective in reducing pain after IUD insertion, but 20% of the participants reported that after the procedure, the injection site was as painful as the IUD placement. The current study was designed to evaluate if there is reduced pain during IUD placement using oral ketorolac 40-60 minutes before the procedure compared to a placebo.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Ketorolac	Oral Tablet
DRUG	Placebo	Oral Tablet

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2017-01-26
• Last updated: 2018-09-26
• Results posted: 2018-09-26