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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement |
|
| placebo | Placebo Comparator | look alike placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | Oral Tablet |
|
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Crawford, MD | OhioHealth | Principal Investigator |
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We will share our published manuscript upon request:
Crawford M, Davy S, Book N, Elliott JO, Arora A. Oral ketorolac for pain relief during intrauterine device insertion: a double-blinded randomized controlled trial. Journal of Obstetrics and Gynaecology Canada 2017, Dec;39(12):1143-1149. doi: 10.1016/j.jogc.2017.05.014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement Ketorolac: Oral Tablet |
| FG001 | Placebo | look alike placebo Placebos |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac | Experimental group |
| BG001 | Placebo | Control group |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Before, during and after IUD placement |
|
|
45 minutes prior and up to 10 minutes post IUD placement
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement Ketorolac: Oral Tablet |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John O. Elliott PhD, MPH Research Specialist Medical Education | OhioHealth | 614-566-3643 | john.elliott@ohiohealth.com |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo |
| Drug |
Oral Tablet |
|
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo | look alike placebo Placebos | 0 | 36 | 0 | 36 | 0 | 36 |
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| D006571 | Heterocyclic Compounds |