Ketorolac for IUD Pain

Overseen By Amy G Bryant, M.D.

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Narcotics, NSAIDs

Disqualifiers: Pregnancy, Infections, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

108 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not use daily narcotics or NSAIDs (non-steroidal anti-inflammatory drugs). If you are currently taking these medications daily, you would need to stop to participate in the trial.

What data supports the effectiveness of the drug ketorolac for IUD pain relief?

Research shows that ketorolac, a strong pain reliever, is effective for managing pain in various medical procedures, including surgeries and IUD placements. It has been found to provide significant pain relief compared to a placebo, making it a promising option for reducing discomfort during IUD insertion. ^{1 2 3 4 5}

Is ketorolac generally safe for use in humans?

Ketorolac is generally safe for short-term use in humans, but it can cause side effects like stomach bleeding, kidney problems, and allergic reactions, especially in high doses or with long-term use. It's important to follow dosage guidelines and avoid use in people with certain conditions like a history of stomach bleeding or kidney issues. ^{1 2 6 7 8}

How does the drug ketorolac differ from other treatments for IUD pain?

Ketorolac is unique for IUD pain management because it can be administered intramuscularly, providing an alternative to oral pain relief methods. This route may offer faster pain relief compared to oral medications, which is beneficial during procedures like IUD placement. ^{1 2 9 10 11}

What is the purpose of this trial?

To determine if oral ketorolac given at different timepoints prior to intrauterine device (IUD) insertion influences pain experienced during this procedure.

Research Team

Amy G Bryant, M.D.

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals who are 18 years or older, can give consent, and want an IUD inserted. It's not for those sedated during IUD placement, replacing an IUD, pregnant, with current infections or certain medical histories like uterine anomalies or allergies to IUD materials.

Inclusion Criteria

Able to consent

I want to have an IUD inserted.

Exclusion Criteria

I had an IUD placed with sedation or anxiety medication.

I am getting my IUD replaced.

I am not pregnant and do not have a genital or pelvic infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive ketorolac or placebo prior to IUD insertion to assess pain reduction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and satisfaction immediately after IUD insertion

10 minutes

1 visit (in-person)

Treatment Details

Interventions

• Ketorolac

Trial Overview The study tests if taking oral ketorolac (a pain reliever) at different times before getting an IUD affects the pain felt during the procedure. Participants will either receive ketorolac or a placebo without knowing which one they get.

Participant Groups

Group I: K2 - Ketorolac 2-hour Active Control 2 Interventions

Receives Ketorolac 20mg PO at 2 hours prior and placebo at 1 hour prior to IUD

Group II: K1 - Ketorolac 1-hour Active Control 2 Interventions

Receives placebo at 2 hours and Ketorolac 20mg PO at 1 hour prior to IUD

Group III: K0 - Placebo control Placebo Group 1 Intervention

Receives placebo at 2 hours and at 1 hour prior to IUD

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Findings from Research

In a study of 67 women, intramuscular ketorolac did not significantly reduce pain during IUD placement compared to a placebo, with median pain scores of 5.2 cm for placebo and 3.6 cm for ketorolac (P=.99).

However, ketorolac was effective in reducing pain at 5 and 15 minutes after IUD placement, indicating it may help with post-procedural discomfort rather than the procedure itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. Ngo, LL., Ward, KK., Mody, SK.[2022]

In a double-blinded randomized controlled trial with 72 participants, oral ketorolac (20 mg) significantly reduced pain during IUD placement compared to a placebo, with pain ratings of 4.2 versus 5.7 at deployment.

Ketorolac also decreased overall pain ratings (3.6 vs. 4.9) and pain 10 minutes after the procedure (1.1 vs. 2.5), demonstrating its efficacy in managing pain associated with IUD insertion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. Crawford, M., Davy, S., Book, N., et al.[2018]

Ketorolac can cause serious side effects like gastrointestinal bleeding and renal impairment, but the risk of these events has decreased since dosage guidelines were revised, making it slightly safer than opioids for pain management.

The risk of adverse effects increases with higher doses, prolonged use beyond 5 days, or in vulnerable populations such as the elderly, highlighting the importance of careful patient selection and adherence to prescribing guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimising the adverse effects of ketorolac. Reinhart, DI.[2018]

A significant portion of ketorolac use in Italy is off-label, with 553 out of 822 reported cases of suspected adverse drug reactions (ADRs) classified as off-label, indicating a widespread practice that raises safety concerns.

Off-label use of ketorolac is associated with a higher incidence of serious ADRs (58.6%) compared to on-label use (39.0%), particularly gastrointestinal events, highlighting the need for careful monitoring and regulation by health authorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions associated with off-label use of ketorolac, with particular focus on elderly patients. An analysis of the Italian pharmacovigilance database and a population based study. Viola, E., Trifirò, G., Ingrasciotta, Y., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ketorolac for Pain Control With Intrauterine Device Placement: A Randomized Controlled Trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Oral Ketorolac for Pain Relief During Intrauterine Device Insertion: A Double-Blinded Randomized Controlled Trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Ketorolac and indomethacin are equally efficacious for the relief of minor postoperative pain. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical implications of ketorolac for postoperative analgesia. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of perioperative ketorolac on pain control in pregnancy termination. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Minimising the adverse effects of ketorolac. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Adverse drug reactions associated with off-label use of ketorolac, with particular focus on elderly patients. An analysis of the Italian pharmacovigilance database and a population based study. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Intramuscular ketorolac for postoperative analgesia following laparoscopic sterilisation. [2019]

10. Italy pubmed.ncbi.nlm.nih.gov

[I.V. ketorolac in the therapy of postoperative pain]. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Intramuscular ketorolac versus oral ibuprofen for pain relief in first-trimester surgical abortion: a randomized clinical trial. [2022]