Oral Ketorolac for Pain Relief During IUD Insertion

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement | Drug: Ketorolac<br>* Oral Tablet<br>* Other names: Toradol;|
| Placebo Comparator: placebo<br>look alike placebo | Drug: Placebo<br>* Oral Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain 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. | Before, during and after IUD placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrauterine device