Oral Ketorolac for Pain Relief During IUD Insertion

NCT ID: NCT03031795

Last Updated: 2018-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

experimental

ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

Oral Tablet

placebo

look alike placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral Tablet

Interventions

Ketorolac

Oral Tablet

Intervention Type: DRUG

Placebo

Oral Tablet

Intervention Type: DRUG

Other Intervention Names

Toradol

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

OhioHealth

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Crawford, MD

Role: PRINCIPAL_INVESTIGATOR

OhioHealth

Other Identifiers

OH1-13-00503

Identifier Type: -

Identifier Source: org_study_id