Oral Ketorolac for Pain Relief During IUD Insertion

OhioHealth

Status and phase

Completed

Phase 4

Conditions

Contraception

Treatments

Drug: Placebo

Drug: Ketorolac

Study type

Interventional

Funder types

Other

Identifiers

NCT03031795

OH1-13-00503

Details and patient eligibility

About

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.

Full 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.

Enrollment

71 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

non-pregnant
English speaking women
18 years of age or older desiring an IUD for contraception

Exclusion criteria

enrollment in another study
pre-medication with any type of analgesic medication
contraindication to an IUD
weight under 50 kg
allergy to non-steroidal anti-inflammatory medications
past medical history of liver disease, renal disease, peptic ulcer disease or recent gastrointestinal bleed,
daily narcotic pain use
positive cultures for gonorrhea or chlamydia.