Ketorolac for Pain During IUD Placement

Overseen By Jill Gassaway

Age: < 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Arkansas Children's Hospital Research Institute

Disqualifiers: Allergy to NSAIDs, Renal impairment, GI bleeding, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ketorolac, a pain-relieving medication, can reduce pain during intrauterine device (IUD) placement for adolescents. IUDs offer reliable birth control, but the placement can be uncomfortable. The study compares two groups: one receiving ketorolac and the other a placebo, both with sedation using propofol. It suits adolescents needing sedated IUD placement at Arkansas Children's Hospital, who do not have certain health issues like kidney problems or stomach ulcers. As a Phase 4 trial, this research aims to understand how ketorolac benefits more patients, given its FDA approval and proven effectiveness.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for ketorolac?

Research has shown that ketorolac is generally safe and effective for pain relief during IUD placement. Although it may not significantly reduce pain during the procedure itself, studies have found that it can lessen pain shortly after, such as 5 to 15 minutes after the IUD is placed. This suggests it might help ease discomfort following the procedure.

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID), similar to ibuprofen. Some individuals might be allergic to ketorolac, and it is not suitable for everyone. However, in medical settings, especially in a controlled environment like a clinical trial, ketorolac is generally considered safe for most people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for pain during IUD placement involve oral pain medications like ibuprofen or local anesthetics. But Ketorolac is unique because it's administered via IV before the procedure, potentially offering faster and more effective pain relief. Researchers are excited about Ketorolac because it acts as a powerful non-steroidal anti-inflammatory drug (NSAID), which could significantly reduce discomfort for patients compared to traditional oral painkillers. This quicker delivery method and the drug's potent anti-inflammatory properties set it apart from the usual options, providing hope for a more comfortable IUD placement experience.

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

Research shows that ketorolac, a type of pain reliever, can help reduce pain after IUD insertion. Studies have found that ketorolac lessens pain 5 and 15 minutes after the procedure. One study showed that taking ketorolac by mouth significantly reduced pain during IUD insertion. In this trial, one group of patients will receive IV ketorolac before IUD placement under sedation, while another group will receive a placebo. Patients who took ketorolac in previous studies reported feeling less pain during and after the procedure compared to those who didn't take it. This suggests that ketorolac could make IUD insertion more comfortable. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy females at Arkansas Children's Hospital who need sedation for IUD placement. It's not suitable for those with allergies to NSAIDs like ketorolac, a history of kidney issues, or past GI bleeding/ulcers.

Inclusion Criteria

Patients requiring sedated IUD placement at Arkansas Children's Hospital

Exclusion Criteria

Allergy to ketorolac or other NSAID

I have had stomach ulcers or bleeding in my digestive tract.

I have a history of kidney problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either IV ketorolac or placebo in combination with propofol for IUD placement under sedation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-procedural pain and total propofol dose for 24 hours after IUD placement

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac

Trial Overview The study tests if ketorolac can reduce pain when given with propofol during and after IUD insertion in adolescents. Participants will either receive ketorolac or a placebo alongside propofol to compare comfort levels.

How Is the Trial Designed?

Group I: Ketorolac Active Control 1 Intervention

The group of patients will receive IV Ketorolac before placement of IUD under sedation.

Group II: Placebo Placebo Group 1 Intervention

The group of patients will receive placebo before placement of IUD under sedation.

Ketorolac is already approved in United States, European Union, Switzerland for the following indications:

Approved in United States as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea
• Idiopathic pericarditis
• Ocular itching

Approved in European Union as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea

Approved in United States as Acular for:

• Ocular itching
• Inflammation after eye surgery

Approved in United States as Sprix for:

• Moderate to severe pain

Approved in Switzerland as Ketorolac for:

• Moderate to severe pain
• Postoperative pain

Who Is Running the Clinical Trial?

Arkansas Children's Hospital Research Institute

Lead Sponsor

Trials

141

Recruited

5,025,000+

Published Research Related to This Trial

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]

Ketorolac tromethamine is an effective nonsteroidal anti-inflammatory analgesic that can be used alone or with opiates for postoperative pain relief, showing promising results compared to morphine sulfate.

Unlike narcotic pain relievers, ketorolac does not cause respiratory depression or nausea, making it a safer option for patients, especially those with respiratory issues or those undergoing short procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac tromethamine: an oral/injectable nonsteroidal anti-inflammatory for postoperative pain control. Redden, RJ.[2019]

In a study involving 176 postoperative patients, ketorolac (10 mg orally) provided analgesic efficacy comparable to both 5 mg and 10 mg doses of morphine, significantly outperforming placebo.

Ketorolac is a safe and effective option for managing acute postoperative pain, serving as a non-opioid alternative to traditional opioid therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of ketorolac in the management of postoperative pain. DeAndrade, JR., Maslanka, M., Maneatis, T., et al.[2022]

In a multicenter study involving patients with moderate to severe inflammation after cataract surgery, ketorolac tromethamine 0.5% was significantly more effective than a placebo in reducing inflammation and associated symptoms like pain and photophobia.

The treatment was found to be safe, with no significant differences in visual acuity or adverse events compared to the placebo, indicating that ketorolac is a reliable option for managing post-surgical inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial. Heier, J., Cheetham, JK., Degryse, R., et al.[2019]

Ketorolac tromethamine is an effective nonsteroidal anti-inflammatory drug (NSAID) for managing moderate to severe postoperative pain, reducing the need for opioid analgesics, which can help minimize opioid-related side effects.

Administered intramuscularly, ketorolac reaches peak plasma levels in about 45 to 50 minutes and has a low incidence of side effects, making it a promising option for both inpatient and outpatient pain management, although further research is needed to fully understand its role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac: a new parenteral nonsteroidal anti-inflammatory drug for postoperative pain management. Lassen, K., Epstein-Stiles, M., Olsson, GL.[2013]

A case study of a 31-year-old man revealed that excessive use of ketorolac tromethamine (Acula) after PRK led to corneal ulceration and perforation, necessitating surgical intervention.

The findings highlight the importance of proper patient education regarding the use of topical NSAIDs post-surgery to prevent complications like corneal damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corneal ulceration and perforation with ketorolac tromethamine (Acular) use after PRK. Mian, SI., Gupta, A., Pineda, R.[2019]

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]

In a randomized study involving patients after extensive colonic resections, the combination of intramuscular ketorolac and patient-controlled intravenous morphine provided equal pain relief compared to morphine alone, without increasing side effects.

The use of ketorolac significantly reduced the need for narcotics by an average of 45%, making it a valuable option for patients at risk of narcotic-related complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac and patient controlled analgesia in the treatment of postoperative pain. Cataldo, PA., Senagore, AJ., Kilbride, MJ.[2013]

In a study involving 200 patients undergoing photorefractive keratectomy, topical ketorolac tromethamine 0.5% was found to provide significantly greater pain relief compared to its vehicle, with patients experiencing less pain intensity and a longer time before needing additional pain medication.

The ketorolac group also reported fewer side effects, such as sleep difficulties and ocular discomfort, and overall, the treatment was deemed safe with minimal adverse events, indicating its efficacy and safety for post-surgery pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy and safety of ketorolac after photorefractive keratectomy. Ketorolac Study Group. Rajpal, RK., Cooperman, BB.[2022]

Citations

1. 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.

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

Oral Ketorolac for Pain Relief During Intrauterine Device ... A recent study showed that intramuscular ketorolac was effective in reducing pain after IUD insertion, but 20% of the participants reported that ...

3. withpower.com withpower.com/trial/ketorolac-for-pain-during-iud-placement-cb5e8

Ketorolac for Pain During IUD Placement In a double-blinded randomized controlled trial with 72 participants, oral ketorolac (20 mg) significantly reduced pain during IUD placement compared to a ...

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

Oral Ketorolac for Pain Relief During Intrauterine Device ... Oral ketorolac given 40 to 60 minutes prior to IUD insertion is effective in reducing pain during IUD deployment, overall pain, and pain 10 minutes after IUD ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01664559?tab=table

A Trial of Ketorolac Prior to Intrauterine Device Placement Ketorolac has not been studied in regards to decreasing pain during and after IUD insertion although it is used by some providers for this purpose.

6. sprix.com sprix.com/pdfs/Sprix_CVA_Womens_Health.pdf

A NON-NARCOTIC, INTRANASAL NSAID THAT ... - SPRIX SPRIX® (ketorolac tromethamine) is contraindicated in the following patients: • Known hypersensitivity to ketorolac or any components of the drug product. • ...

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

Oral Ketorolac for Pain Relief During Intrauterine Device ... Conclusion: Oral ketorolac given 40 to 60 minutes prior to IUD insertion is effective in reducing pain during IUD deployment, overall pain, and pain 10 minutes ...