Contraception
Conditions
Keywords
intrauterine device
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.
Interventions
DRUGKetorolac
Oral Tablet
DRUGPlacebo
Oral Tablet
Sponsors
OhioHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac Experimental group | 35 |
| Placebo Control group | 36 |
| Total | 71 |
Baseline characteristics
| Characteristic | Total | Placebo | Ketorolac |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants | 36 Participants | 35 Participants |
| Age, Continuous | 31.3 years STANDARD_DEVIATION 7.9 | 30.7 years STANDARD_DEVIATION 8.9 | 31.9 years STANDARD_DEVIATION 6.7 |
| Race/Ethnicity, Customized Race/ethnicity Asian | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Black | 15 Participants | 10 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/ethnicity Unknown | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/ethnicity White | 49 Participants | 22 Participants | 27 Participants |
| Region of Enrollment United States | 71 Participants | 36 Participants | 35 Participants |
| Sex: Female, Male Female | 71 Participants | 36 Participants | 35 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 36 |
| other Total, other adverse events | 0 / 35 | 0 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 |
Outcome results
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.
Time frame: Before, during and after IUD placement
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketorolac | Pain Before, During and After IUD Placement | Tenaculum placement | 2.7 units on a scale | Standard Deviation 2.2 |
| Ketorolac | Pain Before, During and After IUD Placement | Deployment of the IUD | 4.2 units on a scale | Standard Deviation 2.9 |
| Ketorolac | Pain Before, During and After IUD Placement | Pre-procedure pain rating | 0.4 units on a scale | Standard Deviation 1 |
| Ketorolac | Pain Before, During and After IUD Placement | Overall pain rating during the procedure | 3.6 units on a scale | Standard Deviation 2.9 |
| Ketorolac | Pain Before, During and After IUD Placement | Pain expected during the procedure | 4.1 units on a scale | Standard Deviation 2.2 |
| Ketorolac | Pain Before, During and After IUD Placement | Level of pain 10 minutes post procedure | 1.1 units on a scale | Standard Deviation 1.5 |
| Ketorolac | Pain Before, During and After IUD Placement | Uterine sounding | 3.3 units on a scale | Standard Deviation 2.9 |
| Placebo | Pain Before, During and After IUD Placement | Level of pain 10 minutes post procedure | 2.5 units on a scale | Standard Deviation 2.5 |
| Placebo | Pain Before, During and After IUD Placement | Pain expected during the procedure | 4.5 units on a scale | Standard Deviation 2.4 |
| Placebo | Pain Before, During and After IUD Placement | Tenaculum placement | 3.2 units on a scale | Standard Deviation 2.4 |
| Placebo | Pain Before, During and After IUD Placement | Uterine sounding | 4.2 units on a scale | Standard Deviation 2.9 |
| Placebo | Pain Before, During and After IUD Placement | Deployment of the IUD | 5.7 units on a scale | Standard Deviation 2.9 |
| Placebo | Pain Before, During and After IUD Placement | Overall pain rating during the procedure | 4.9 units on a scale | Standard Deviation 2.7 |
| Placebo | Pain Before, During and After IUD Placement | Pre-procedure pain rating | 0.7 units on a scale | Standard Deviation 1.5 |
Comparison: A 2 point difference was used to power the study. This is consistent with previous definitions of a clinically meaningful reductions in pain and provides a visually meaningful change on the 0-10 numerical rating scale with anchors at every other point, for example moving from very severe (8) to severe pain (6) or from moderate pain (4) to mild pain (2).p-value: <0.05Wilcoxon rank sum test