A Phase 4 interventional study of Ketorolac and Placebo in Contraception, sponsored by OhioHealth. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-26.
Sponsored by OhioHealth · Phase 4, Interventional, and Treatment
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.
OhioHealth is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement
Drug: Ketorolac
look alike placebo
Drug: Placebo
Oral Tablet
Also known as: Toradol
Oral Tablet
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.
Time frame: Before, during and after IUD placement
| Milestone | Experimental | Placebo |
|---|---|---|
| Started | 35 | 36 |
| Completed | 35 | 35 |
| Not completed | 0 | 1 |
Pain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.
| units on a scale | Ketorolac | Placebo |
|---|---|---|
| Pain expected during the procedure | 4.1 ± 2.2 | 4.5 ± 2.4 |
| Pre-procedure pain rating | 0.4 ± 1.0 | 0.7 ± 1.5 |
| Tenaculum placement | 2.7 ± 2.2 | 3.2 ± 2.4 |
| Uterine sounding | 3.3 ± 2.9 | 4.2 ± 2.9 |
| Deployment of the IUD | 4.2 ± 2.9 | 5.7 ± 2.9 |
| Overall pain rating during the procedure | 3.6 ± 2.9 | 4.9 ± 2.7 |
| Level of pain 10 minutes post procedure | 1.1 ± 1.5 | 2.5 ± 2.5 |
Collected over 45 minutes prior and up to 10 minutes post IUD placement. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Placebo | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Age, Categorical(Participants) | Ketorolac | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 35 | 36 | 71 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Ketorolac | Placebo | Total |
|---|---|---|---|
| Mean | 31.9 ± 6.7 | 30.7 ± 8.9 | 31.3 ± 7.9 |
| Sex: Female, Male(Participants) | Ketorolac | Placebo | Total |
|---|---|---|---|
| Female | 35 | 36 | 71 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Ketorolac | Placebo | Total |
|---|---|---|---|
| Race/ethnicity — White | 27 | 22 | 49 |
| Race/ethnicity — Black | 5 | 10 | 15 |
| Race/ethnicity — Hispanic | 0 | 1 | 1 |
| Race/ethnicity — Asian | 1 | 1 | 2 |
| Race/ethnicity — Other | 2 | 2 | 4 |
| Race/ethnicity — Unknown | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Ketorolac | Placebo | Total |
|---|---|---|---|
| United States | 35 | 36 | 71 |
No study locations are listed for this record.
Plan to share: No — 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.
No publications or documents are linked to this record.
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