Oral Ketorolac for Pain Relief During IUD Insertion

Phase 4

Completed

• Conditions: Contraception
• Interventions: Drug: Placebo; Drug: Ketorolac

• Registration Number: NCT03031795
• Lead Sponsor: OhioHealth

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.

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-11-30
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-26
• Results First Submitted: 2017-09-13
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-28
• Last Update Submitted: 2018-08-28
• Results First Posted: 2018-09-26
• Last Update Posted: 2018-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	look alike placebo
experimental	Ketorolac	ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement

Primary Outcome Measures

Name	Time	Method
Pain Before, During and After IUD Placement	Before, during and after IUD placement	Pain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.