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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether taking ketorolac, a pain reliever, at different times before an intrauterine device (IUD) insertion can reduce procedural pain. Participants will be divided into groups: some will receive ketorolac two hours before the procedure, others one hour before, and a control group will receive a placebo. The study seeks individuals who want an IUD and can consent to participate, excluding those with certain medical conditions like past pelvic infections or allergies to NSAIDs (non-steroidal anti-inflammatory drugs). As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ketorolac is generally safe and effective for pain relief during the placement of an intrauterine device (IUD). Studies indicate that while ketorolac might not significantly reduce pain during insertion, it eases pain shortly after, specifically at 5 and 15 minutes post-procedure. This makes the medication effective for immediate pain relief following IUD placement.

Regarding safety, the FDA has approved ketorolac for other uses, indicating thorough testing for those purposes. This approval confirms that its safety is well-understood, and any common side effects are known. Most people do not experience serious side effects when using ketorolac as directed for short-term pain relief. However, some may experience mild side effects, such as an upset stomach or headache.

In summary, ketorolac is a well-researched drug with a known safety record, particularly for short-term use in pain relief situations like IUD placement. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IUD pain?

Researchers are excited about using Ketorolac for managing IUD insertion pain because it offers a potentially faster and targeted pain relief option. Unlike typical pain relievers like ibuprofen or acetaminophen, Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that directly reduces inflammation and pain. This trial explores whether taking Ketorolac either two hours or one hour before IUD insertion can effectively ease discomfort more efficiently than standard treatments. This approach could provide a more precise timing for pain management, enhancing comfort during the procedure.

What evidence suggests that ketorolac might be an effective treatment for IUD pain?

Research has shown that ketorolac can help reduce pain after an IUD (intrauterine device) insertion. In some studies, participants reported less pain 5 to 15 minutes after the procedure when they took ketorolac beforehand. This trial will administer ketorolac at different times before the procedure to assess its effectiveness. Although this medication might not reduce pain during the IUD insertion itself, it appears to help shortly afterward. Participants who took ketorolac experienced better pain relief compared to those who received a placebo, suggesting that ketorolac could effectively ease discomfort after the procedure. ^{1 3 4 6 7}

Who Is on the Research Team?

Amy G Bryant, M.D.

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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

I want to have an IUD inserted.

Able to consent

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28826645/

Oral Ketorolac for Pain Relief During Intrauterine Device ... The primary outcome was pain reduction (measured on a 0-10 numerical rating scale) during IUD placement. Data was analyzed using a two-sided ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4527080/

Ketorolac for Pain Control With Intrauterine Device ... Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01664559?cond=Pain%20Management&intr=Devices&locStr=United%20States&country=United%20States&rank=3

A Trial of Ketorolac Prior to Intrauterine Device Placement We hypothesize that administration of ketorolac 30mg intramuscularly at least 30 minutes prior to IUD insertion will decrease pain scores by at least 20mm on a ...

4. jogc.com jogc.com/article/S1701-2163(17)30279-7/abstract

Oral Ketorolac for Pain Relief During Intrauterine Device ... The primary outcome was pain reduction (measured on a 0–10 numerical rating scale) during IUD placement. Data was analyzed using a two-sided independent samples ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/13625187.2024.2398440

Full article: Pain relief during intrauterine device placement ... We found that the treatment with ketorolac and an analgesic was better than the placebo when the pain was evaluated 10 min post‐IUD insertion.

6. jogc.com jogc.com/article/S1701-2163(17)30279-7/fulltext

Oral Ketorolac for Pain Relief During Intrauterine Device ... The primary outcome was pain reduction (measured on a 0–10 numerical rating scale) during IUD placement. Data was analyzed using a two-sided ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26241253/

Ketorolac for Pain Control With Intrauterine Device Placement Conclusion: Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement. Clinical trial registration: ...