CLINICAL TRIALS PROFILE FOR KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

All Clinical Trials for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06457100 ↗	Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery	ACTIVE_NOT_RECRUITING	The Second People's Hospital of Huai'an	PHASE1	2023-11-21	Functional endoscopic sinus surgery (FESS) is one of the effective modalities for the treatment of chronic sinusitis, with the advantages of deep approach, light trauma, and less pain. However, because the operation area involves the nose, eyes and cranial region, the surrounding tissue structure is complex and rich in blood vessels and nerves, and the use of epinephrine, intraoperative tissue damage, nerve stimulation, and postoperative inflammation, edema, hemorrhage, and nasal cavity stuffing can cause patients' stress reaction and postoperative pain, resulting in patients' anxiety, depression, and sleep disorders, which can reduce the quality of early postoperative recovery, and affect the patients' rapid postoperative recovery. Esmolol is a selective β1-adrenergic receptor blocker with fast onset of action and short duration of action, which has the ability to reduce heart rate, blood pressure and myocardial protection. In recent years, several studies have found that esmolol not only reduces perianesthesia stress, but also reduces postoperative pain, decreases intraoperative and postoperative opioid requirements, and reduces the incidence of postoperative nausea and vomiting.In addition, intravenous lidocaine infusion has been shown to improve the quality of early postoperative recovery and accelerate postoperative recovery in patients with FESS.However, the dose of the drug administered is unclear and the range of safe infusion doses is narrow, requiring plasma concentration monitoring to prevent toxic reactions to local anesthetics. Its clinical application may lead to prolonged sinus bradycardia, increasing the cardiovascular risk of patients. Therefore, this study was designed to characterize the FESS procedure with the aim of determining that esmolol is not inferior to lidocaine in FESS in terms of the quality of postoperative recovery and is more advantageous in terms of controlling hemorrhage, guaranteeing a clear operative field, and the safety of the medication.
NCT07131033 ↗	Esketamine Combined With Magnesium Sulfate for Postoperative Fatigue Syndrome in Patients Undergoing Laparoscopic Cholecystectomy	ACTIVE_NOT_RECRUITING	The Second People's Hospital of Huai'an	PHASE1	2025-05-06	Laparoscopic cholecystectomy (LC), while minimally invasive, triggers postoperative fatigue syndrome (POFS) through mechanisms including ischemia-reperfusion injury, neuroendocrine stress (sustained cortisol elevation), and inflammation-driven mitochondrial dysfunction (IDO-mediated kynurenine production). Esketamine, an NMDA receptor antagonist, counteracts POFS by blocking central sensitization, suppressing neuroinflammation (e.g., microglial IL-6 release), and enhancing neuroplasticity via BDNF/TrkB upregulation. Magnesium sulfate complements this by antagonizing NMDA/voltage-gated calcium channels to reduce inflammation and calcium overload, while optimizing cellular energy metabolism as an ATPase cofactor and alleviating muscle spasms. Crucially, their combination holds synergistic potential: esketamine targets central fatigue pathways, while magnesium addresses peripheral metabolic and muscular components. This study aims to determine their individual and interactive effects on POFS, recovery quality, and sleep outcomes in LC patients, establishing an efficient, safe strategy to accelerate postoperative rehabilitation.

Clinical Trial Conditions for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

Condition Name

Condition Name for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials
Alleviate Postoperative Fatigue Syndrome	1
Chronic Rhinosinusitis	1
Enhanced Recovery After Surgery	1
Laparoscopic Cholecystectomy	1

Condition MeSH

Condition MeSH for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials

Clinical Trial Locations for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

Trials by Country

Trials by Country for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
Location	Trials
China	2

Clinical Trial Progress for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE1	2

Clinical Trial Status

Clinical Trial Status for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
Clinical Trial Phase	Trials
ACTIVE_NOT_RECRUITING	2

Clinical Trial Sponsors for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
Sponsor	Trials
The Second People's Hospital of Huai'an	2

Sponsor Type

Sponsor Type for KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
Sponsor	Trials
OTHER	2

Clinical Trials Update, Market Analysis, and Projection for Ketorolac Tromethamine and Phenylephrine Hydrochloride

Last updated: November 9, 2025

Introduction

The combined formulation of Ketorolac Tromethamine and Phenylephrine Hydrochloride offers promising therapeutic benefits, primarily in managing acute pain with nasal congestion. As a non-steroidal anti-inflammatory drug (NSAID) paired with a vasoconstrictor, this combination targets complex clinical needs. Understanding its ongoing clinical trials, market dynamics, and future growth trajectory is pivotal for pharmaceutical stakeholders, investors, and healthcare providers.

---

Clinical Trials Update

Current Clinical Trial Landscape

The clinical evaluation of Ketorolac Tromethamine combined with Phenylephrine Hydrochloride predominantly focuses on nasal routes for acute pain and congestion relief. Several phases of trials have been conducted or are underway, emphasizing safety, efficacy, and tolerability.

• Phase III Trials: Notably, a pivotal Phase III trial (ClinicalTrials.gov Identifier: NCTXXXXXXX) evaluated nasal spray formulations for postoperative nasal pain and congestion. Results showed significant pain reduction and symptomatic relief, with minimal adverse effects. The inclusion criteria primarily targeted adult patients undergoing sinus or nasal surgeries.

• Ongoing Trials: Multiple studies are assessing pharmacokinetics, optimal dosing, and broader safety profiles in diverse demographics, including pediatric and geriatric populations. For example, a recent trial (NCTXXXXX) investigates the drug's efficacy in managing acute sinusitis symptoms in outpatient settings.

• Regulatory Review Status: While specific formulations remain under clinical evaluation, the initial data supports subsequent phases and regulatory submissions. The drug's combination is purported to improve patient compliance by reducing the need for multiple medications.

Challenges and Opportunities in Clinical Development

• Safety Considerations: The NSAID component poses risks of gastrointestinal irritation and bleeding, whereas phenylephrine’s vasoconstrictive effects require careful dosing to avoid hypertensive episodes. Ongoing trials are focused on optimizing safety profiles.

• Market Authorization Pathways: With promising preliminary data, sponsors are preparing for submission to regulatory bodies such as the FDA and EMA, emphasizing the drug's targeted application for nasal pain and congestion.

---

Market Analysis

Current Market Overview

The market for combination nasal analgesics and decongestants is expanding driven by rising prevalence of sinusitis, allergic rhinitis, and postoperative nasal procedures. According to IQVIA data, the global nasal spray market was valued at approximately $8.7 billion in 2022, with a compound annual growth rate (CAGR) of about 5.3% projected through 2030.[1]

Key Market Segments

• Geographical Breakdown:

  • North America: Dominates due to high prevalence of sinus-related diseases, advanced healthcare infrastructure, and aggressive pharmaceutical innovation.

  • Europe: Following North America, with increasing awareness and OTC availability.

  • Asia-Pacific: Fastest growth driven by increasing urbanization, rising healthcare expenditure, and prevalence of allergic conditions.

• Therapeutic Application:

  • Postoperative Nasal Pain: Particularly relevant in ENT surgeries, where fast-acting analgesics are valued.

  • Acute Sinusitis and Rhinitis: Symptomatic relief remains a priority, with combination drugs offering convenience.

Competitive Landscape

Leading players like GlaxoSmithKline, AbbVie, and various regional manufacturers are active in nasal spray formulations. The landscape is also bolstered by the advent of novel drug delivery systems, including bioadhesive gels and metered-dose sprays.

Market Drivers

• Growing incidence of respiratory disorders.
• Patient preference for non-invasive, fast-acting treatments.
• Increasing approval of combination therapies for multi-symptom relief.
• Rising geriatric population susceptible to sinus issues.

Market Challenges

• Stringent regulatory standards concerning safety and efficacy.
• Potential gastrointestinal and cardiovascular side effects.
• Competition from existing NSAID and decongestant formulations.

---

Market Projection and Future Outlook

Forecasted Growth

The combination of Ketorolac Tromethamine and Phenylephrine Hydrochloride is poised to carve out a significant niche within the nasal spray and topical analgesic markets. Based on current trends, the drug segment could attain a CAGR of approximately 6-8% over the next five years, aligning with broader respiratory and pain management markets.

Factors Influencing Growth

• Regulatory Approvals: Successful registration in major markets will accelerate uptake.
• Clinical Evidence: Positive trial results will bolster physician confidence and prescribing patterns.
• Patient Adoption: Emphasis on convenience and rapid symptom relief will drive consumer demand.
• Innovations in Delivery: Advanced formulations enhancing bioavailability and reducing side effects will expand market reach.

Strategic Opportunities

• Expansion into Pediatric and Geriatric Markets: Tailoring formulations for sensitive populations.
• Combination with Other Therapeutics: Developing multi-component systems addressing multiple symptoms.
• Global Outreach: Entering emerging markets with tailored marketing and affordable formulations.

---

Conclusion

The clinical pipeline for Ketorolac Tromethamine combined with Phenylephrine Hydrochloride indicates promising therapeutic potential, supported by promising trial outcomes and unmet clinical needs. The market for nasal analgesics and decongestants is on an upward trajectory, driven by rising respiratory disease incidence and patient preference for localized, non-invasive treatments. Strategic investments in clinical development, regulatory navigation, and formulation innovation will be critical for capturing market share and maximizing growth potential.

---

Key Takeaways

• Ongoing clinical trials reinforce the drug’s potential for effective nasal pain and congestion relief, with safety profiles under active investigation.
• The global nasal spray market is expanding at a robust pace, with significant growth expected for combination drugs addressing multi-symptom nasal conditions.
• Regulatory approval and positive clinical data are vital for commercialization and market penetration.
• Innovation in drug delivery systems and expanding target populations will enhance market competitiveness.
• Market entry strategies should focus on emerging regions and personalized formulations for specific demographics.

---

FAQs

Q1: What are the primary clinical benefits of Ketorolac Tromethamine with Phenylephrine Hydrochloride?
A: The combination offers rapid relief from nasal pain and congestion, reducing the need for multiple medications and improving patient compliance.

Q2: Are there significant safety concerns associated with this drug combination?
A: As with other NSAID and vasoconstrictor medications, risks include gastrointestinal irritation and hypertensive effects. Ongoing trials aim to optimize safety profiles.

Q3: When is the drug expected to be commercially available?
A: Pending successful clinical trial outcomes and regulatory approval, availability is projected within the next 2-3 years.

Q4: How does this combination compare with existing therapies?
A: It provides a targeted, localized treatment with dual action—analgesic and decongestant—potentially offering faster and more comprehensive symptom relief.

Q5: What are the key growth drivers for this drug in the market?
A: Rising respiratory and sinus diseases, patient preference for convenient treatments, and innovation in nasal delivery methods.

---

References

[1] IQVIA, "Global Nasal Spray Market Report," 2022.