Oral Ketorolac for Pain Relief During IUD Insertion

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031795
• Other study ID #: OH1-13-00503
• Status: Completed
• Phase: Phase 4
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: August 2018
• Source: OhioHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Ketorolac
Oral Tablet
• Placebo
Oral Tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OhioHealth

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Before, during and after IUD placement