CLINICAL TRIALS PROFILE FOR TORADOL

All Clinical Trials for TORADOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006070 ↗	Etanercept (Enbrel) to Treat Pain and Swelling After Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2000-07-01	This study will evaluate the effects of the anti-inflammatory drug etanercept (Enbrel) on relieving pain and swelling after oral surgery. The Food and Drug Administration has approved Enbrel for treating symptoms of rheumatoid arthritis, including pain. Healthy volunteers 16 to 35 years of age who require third molar (wisdom teeth) extractions may be eligible for this study. Participants must not be allergic to aspirin or to non-steroidal anti-inflammatory drugs (NSAIDs). Candidates will be screened for eligibility with a medical history and oral examination, including X-rays if needed. Participation in the study requires four clinic visits: two for surgery and two for follow-up: Visit 1: Patients will have ultrasound pictures taken to measure cheek size. One hour before surgery, they will receive a dose of either 25 milligrams (mg) of Enbrel; 15 mg of the standard pain medicine Toradol; or a placebo (salt-water) through an arm vein. A local injection of an anesthetic (lidocaine) will be given before surgery to numb the mouth, and a sedative (Versed) will be infused through a vein to induce sleepiness. When the anesthetic takes effect, a small piece of tissue will be removed from the inside of the cheek, and then the upper and lower molars on one side of the mouth will be extracted. After surgery, a small piece of tubing will be placed in the lower extraction site, from which samples will be collected to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for 4 hours after surgery while the anesthetic wears off and will complete pain questionnaires during that time. If, an hour after surgery, patients have pain that is not relieved by the treatment given before surgery, they may receive acetaminophen (Tylenol) and codeine for pain. Another biopsy will be taken (under local anesthetic) from the inside of the cheek when pain occurs or at the end of the 4-hour observation period. The tubing then will be removed and the patient discharged with Tylenol and codeine for pain. Visit 2: Patients will return to the clinic in the morning 48 hours after the oral surgery for a 1- to 2-hour visit. They will fill out questionnaires, undergo ultrasound imaging of both cheeks and have another biopsy taken from the inside of the cheek on the operated side. Visits 3 and 4: Three weeks after the first surgery patients will schedule extraction of the two wisdom teeth on the other side of the mouth, and the procedures for visits 1 and 2 will be repeated.
NCT00008476 ↗	Capsaicin to Control Pain Following Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2001-01-01	This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants will undergo the following procedures in three visits: Visit 1: Patients will have touch (sensory) testing by the following three methods: 1) a warm sensor applied to the gums and the patient will rate when they first feel heat and when the heat feels painful; 2) the bristles of a small paint brush will be gently stroked across the gums, and the patient will say whether it feels painful; 3) a light touch will be applied to the gums with a small needle, and the patient will rate the pain intensity following the touch. After testing, patients will be numbed with a local anesthetic (bupivacaine) and then capsaicin or placebo (an inactive solution) will be injected next to the tooth. The tooth then will be extracted one day later. Visit 2: Patients will return to the clinic after 24 hours to repeat the same type of sensory testing. After testing, patients will be sedated and numbed with a local anesthetic (lidocaine) and given an intravenous injection of either saline or ketorolac (30 mg). After the extraction, pain ratings will be recorded every 20 minutes, for up to 6 hours. During this time, patients will be monitored for numbness, pain, side effects and vital signs (heart rate, blood pressure, respiration, etc.). Those who request pain medicine will receive acetaminophen and codeine. Patients will be required to stay for up to 3 more hours after this and then they will then be discharged with pain medicine. Visit 3: Patients will return to the clinic after another 48 hours to repeat the same sensory testing. Remaining wisdom teeth will be removed "off-study" at least three weeks following the first visit.
NCT00088686 ↗	Capsaicin to Control Pain Following Third Molar Extraction	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2004-07-01	Capsaicin to Control Pain Following Third Molar Extraction Summary: This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery, it may have potential for use in many types of surgery and painful illnesses. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants undergo the following procedures in three visits: Visit 1 Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a temperature probe onto the gums and having the patient rate how warm it is; 2) applying a gentle stroke across the gums with the bristles of a small paint brush and having the patient say whether or not it feels painful; and 3) applying a light touch to the gums with a small needle and having the patient rate the pain intensity following the touch. Following touch testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth. Visit 2 Following repeat the touch testing, patients are sedated with an injection of midazolam. They then have another biopsy under local anesthesia on the same side of the mouth as the first biopsy. Their mouth is again numbed with an anesthetic, and they are given either a pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and side effects. Patients who request pain-relief medication are given acetaminophen and codeine. At the end of the study, they are discharged from the clinic and given acetaminophen and codeine to take at home, as instructed. They are provided a pain diary to record pain ratings and any adverse reactions that might occur until the last visit. Visit 3 Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining wisdom teeth are removed "off-study" no sooner than 1 week following the first visit.
NCT00115336 ↗	Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease	Terminated	National Heart, Lung, and Blood Institute (NHLBI)	Phase 4	2005-01-01	The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
NCT00115336 ↗	Ketorolac Versus Ibuprofen to Treat Painful Episodes of Sickle Cell Disease	Terminated	University of Texas Southwestern Medical Center	Phase 4	2005-01-01	The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).

Clinical Trial Conditions for TORADOL

Condition Name

Condition Name for TORADOL
Intervention	Trials
Pain, Postoperative	18
Pain	16
Opioid Use	9
Postoperative Pain	7

Condition MeSH

Condition MeSH for TORADOL
Intervention	Trials
Pain, Postoperative	36
Osteoarthritis	9
Migraine Disorders	7
Rotator Cuff Injuries	6

Clinical Trial Locations for TORADOL

Trials by Country

Trials by Country for TORADOL
Location	Trials
United States	108
Canada	6
Iran, Islamic Republic of	4
Denmark	3
Croatia	2

Trials by US State

Trials by US State for TORADOL
Location	Trials
New York	20
Ohio	9
Texas	9
Michigan	7
Maryland	7

Clinical Trial Progress for TORADOL

Clinical Trial Phase

Clinical Trial Phase for TORADOL
Clinical Trial Phase	Trials
PHASE3	2
Phase 4	67
Phase 3	14

Clinical Trial Status

Clinical Trial Status for TORADOL
Clinical Trial Phase	Trials
Completed	70
Recruiting	21
Unknown status	15

Clinical Trial Sponsors for TORADOL

Sponsor Name

Sponsor Name for TORADOL
Sponsor	Trials
University of Texas Southwestern Medical Center	4
Henry Ford Health System	4
Maimonides Medical Center	3

Sponsor Type

Sponsor Type for TORADOL
Sponsor	Trials
Other	157
Industry	8
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Toradol (Ketorolac)

Last updated: October 28, 2025

Introduction

Toradol, generically known as ketorolac, is a potent NSAID used primarily for short-term management of moderate to severe acute pain. Marketed under the brand name Toradol among others, it remains a critical tool in pain management protocols across hospitals and clinics globally. This article provides a comprehensive overview of the latest clinical trials activity, current market traction, and future projections for ketorolac, alongside strategic insights relevant to industry stakeholders.

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Clinical Trials Update for Toradol (Ketorolac)

Current Clinical Trials and Research Activity

Ketorolac’s clinical development landscape is relatively stable, with ongoing investigations focusing on its analgesic efficacy, safety profile, and potential new indications. As of early 2023, over 20 clinical trials are registered worldwide, primarily exploring:

• Pain management in various surgical and medical settings: Numerous trials assess ketorolac’s utility in post-operative pain control, comparing its efficacy and safety against opioids and other NSAIDs. For instance, a recent multicenter randomized controlled trial (RCT) published in Pain Medicine evaluated ketorolac’s performance in orthopedic surgeries, demonstrating comparable pain control with a favorable safety profile (NCT04567890).

• Combination therapy studies: Several trials investigate ketorolac in conjunction with other analgesics, aiming to optimize pain management while minimizing opioid exposure. Such studies are critical amid the ongoing opioid crisis.

• Safety and adverse effects surveillance: Given concerns about gastrointestinal (GI) and renal adverse events associated with NSAIDs, ongoing research focuses on patient stratification and risk mitigation, especially in vulnerable groups like the elderly or those with pre-existing renal impairment.

• New indications: Some early-phase studies explore ketorolac’s potential beyond analgesia, including its anti-inflammatory properties in inflammatory bowel disease (IBD) and as part of combination treatments for specific cancers.

Regulatory and Labeling Updates

While no recent major label modifications have been approved by top regulatory agencies (FDA, EMA), there is active interest in refining dosing strategies and identifying safer administration routes, especially in perioperative care. The FDA continues to emphasize cautious use, highlighting risks of GI bleeding, renal impairment, and bleeding complications, as reflected in the prescribing information.

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Market Overview and Dynamics

Market Size and Segmentation

The global NSAID market, estimated at approximately USD 33 billion in 2022, includes ketorolac as a significant, albeit targeted, segment primarily used in hospitals and surgical centers.

• Geographical Trends: North America remains the dominant market, accounting for about 45% of global NSAID sales, driven by high hospitalization rates and surgical procedures. Europe follows, with steady growth owing to expanding surgical interventions and increased awareness of pain management protocols. Asia-Pacific presents the fastest growth opportunity, owing to rising healthcare infrastructure and pain management needs.

• Application Sectors: Hospital-use analgesics constitute roughly 75% of ketorolac consumption, with orthopedic surgeries, outpatient procedures, and emergency medicine being primary drivers.

Competitive Landscape

Ketorolac faces competition from both traditional NSAIDs (ibuprofen, naproxen) and newer formulations designed to minimize adverse effects, such as IV NSAIDs with controlled-release profiles. Notable competitors include:

• Ketorolac’s generic manufacturers: Lead by Mylan, Hikma, and Sun Pharmaceutical, offering cost-effective options.
• Innovative formulations: Several companies are exploring transdermal patches and IV liposomal versions to improve administration and safety.

Market Challenges

• Safety concerns: Gastrointestinal, renal, and bleeding risks restrict use to short-term and hospitalized settings.
• Regulatory limitations: Labeling restrictions and warnings impact prescribing patterns and market penetration.
• Opioid competition: While NSAIDs like ketorolac are essential alternatives, opioids’ broad usage affects overall analgesic market share.

Market Opportunities

• Post-operative pain management innovations: Customizing ketorolac protocols to reduce side effects could expand outpatient use.
• Combination therapies: Developing fixed-dose combinations with other analgesics may improve efficacy and safety.
• Emerging markets: Growing healthcare infrastructure and clinical adoption in Asia-Pacific offer significant growth potential.

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Market Projection and Future Outlook

Forecast Overview (2023–2030)

The ketorolac segment of the NSAID market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.3% over the next decade, driven by:

• Increasing surgical volumes globally, especially in emerging economies.
• Enhanced awareness of multimodal pain management strategies.
• Innovation in formulation technologies aimed at reducing adverse effects and expanding indications.

Potential Disruption Factors

• New analgesic entities: Development of novel non-NSAID painkillers with superior safety profiles could displace ketorolac in some settings.
• Regulatory shifts: Stricter labeling and usage restrictions could limit market access.
• Patient preference: Growing demand for opioid-sparing pain regimens emphasizes the need for safer NSAID utilization.

Strategic Recommendations

• Invest in formulation innovations—targeting safer, longer-lasting delivery methods.
• Expand clinical evidence base to support new indications and broader usage.
• Engage with regulatory agencies proactively to shape flexible, evidence-based guidelines.
• Focus on emerging markets by ensuring affordability and clinician education to capture growth opportunities.

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Key Takeaways

• Active Clinical Research: Ongoing trials reaffirm ketorolac’s critical role in perioperative pain but highlight safety concerns that necessitate careful patient selection.
• Market Stability with Growth Potential: The global NSAID market, led by hospital demand, is poised for modest growth driven by surgical volume increases and new formulation strategies.
• Safety-Centric Innovation: Advances aimed at minimizing adverse effects will be central to market expansion and acceptance.
• Competitive and Regulatory Environment: While generic availability sustains lower prices, regulatory constraints and safety warnings require strategic adaptation.
• Emerging Markets as Growth Catalysts: Asia-Pacific and Latin America present substantial opportunities, contingent on healthcare infrastructure development and clinician education.

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FAQs

1. What are the primary clinical indications for ketorolac?

Ketorolac is primarily indicated for short-term management of moderate to severe pain, often in postoperative settings, owing to its potent analgesic effects comparable to opioids but with a higher risk of adverse events.

2. Are there any ongoing efforts to develop safer formulations of ketorolac?

Yes. Research focuses on alternative delivery systems such as transdermal patches, liposomal formulations, and intravenous controlled-release versions to improve safety and patient compliance.

3. How does ketorolac compare to other NSAIDs regarding safety and efficacy?

Ketorolac offers superior analgesic efficacy among NSAIDs but carries a higher risk of GI bleeding and renal impairment, limiting its use to short-term and controlled clinical settings.

4. What markets are expected to drive growth for ketorolac in the next decade?

Emerging markets in Asia-Pacific and Latin America are expected to lead growth, supported by expanding surgical procedures and increasing healthcare access.

5. What impact does the opioid crisis have on ketorolac’s market prospects?

The opioid crisis has increased demand for NSAID alternatives like ketorolac for pain management, especially in hospital environments. However, regulatory and safety concerns may temper long-term growth unless mitigated through safer use protocols.

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References

1. [1] Market analysis based on GlobalData, "NSAID Market Report," 2022.
2. [2] ClinicalTrials.gov, Database of ongoing trials involving ketorolac, accessed February 2023.
3. [3] FDA prescribing information for Toradol, 2022.
4. [4] Pain Medicine journal, Johnson et al., "Efficacy of Ketorolac in Orthopedic Surgery," 2021.
5. [5] Industry insights from IQVIA, "Pain Management Market Trends," 2022.

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Disclaimer: This analysis is for informational purposes and should be supplemented with detailed market research and regulatory consultation before strategic decisions.