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

Trial Summary

What is the purpose of this trial?

Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement. Propofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement.. The current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.

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 data supports the effectiveness of the drug Ketorolac for pain relief during IUD placement?

Research shows that oral ketorolac can provide effective pain relief during the placement of an intrauterine device (IUD), as demonstrated in a double-blinded randomized controlled trial. ^{1 2 3 4 5}

Is ketorolac generally safe for use in humans?

Ketorolac, used for managing pain, is generally considered safe for short-term use in humans, with low reported side effects. However, there have been rare cases of serious eye complications when used in high doses for eye conditions. ^{1 2 4 6 7}

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

Ketorolac is unique because it is a nonsteroidal anti-inflammatory drug (NSAID) that can be administered intramuscularly, providing pain relief without the side effects associated with narcotics, such as respiratory depression and nausea. This makes it a novel option for pain management during IUD placement, especially for those who may have respiratory issues or prefer to avoid narcotics. ^{3 4 5 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

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

Analgesic efficacy and safety of ketorolac after photorefractive keratectomy. Ketorolac Study Group. [2022]

2. United States 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. [2019]

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

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

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

Corneal ulceration and perforation with ketorolac tromethamine (Acular) use after PRK. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Ketorolac: a new parenteral nonsteroidal anti-inflammatory drug for postoperative pain management. [2013]

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

The use of ketorolac in the management of postoperative pain. [2022]

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

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

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

Ketorolac and patient controlled analgesia in the treatment of postoperative pain. [2013]