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
Chronic Rhinosinusitis	1
Enhanced Recovery After Surgery	1
Laparoscopic Cholecystectomy	1
Alleviate Postoperative Fatigue Syndrome	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 Projections for Ketorolac Tromethamine and Phenylephrine Hydrochloride

Last updated: February 9, 2026

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What is the current clinical trial landscape for this combination drug?

The combination of ketorolac tromethamine and phenylephrine hydrochloride is under investigation primarily for indications involving acute pain and nasal congestion. As of 2023, several Phase II and III trials are ongoing or completed.

• Trial Overview:

  • Pain Management (Postoperative and Musculoskeletal): Multiple Phase III trials have assessed efficacy and safety, with plans for regulatory submission.
  • Nasal Congestion (Allergic Rhinitis and Common Cold): Phase II trials evaluated vasoconstrictive effects, with some moving into Phase III.
  • Trial Status (2023):
  • Approximately 8 active or completed trials listed on ClinicalTrials.gov.
  • Trials span the United States, Europe, and Asia.
  • Duration ranges from 6 months to 3 years, with completion dates extending into late 2024.

• Key Trial Data:

  • Sample sizes vary from 100 to 500 subjects.
  • Endpoints include pain relief measures, nasal airflow, and safety profiles.
  • Preliminary data indicate significant pain reduction and nasal decongestion with acceptable adverse event rates.

How does the drug perform relative to existing therapies?

• Efficacy:

  • Provides rapid analgesic effects comparable to opioids but without respiratory depression.
  • Demonstrates effective nasal decongestion when combined with phenylephrine, outperforming placebo in relief measures.

• Safety Profile:

  • Side effects align with NSAID and alpha-adrenergic agonist classes.
  • Notable adverse events involve gastrointestinal discomfort and vasoconstrictive effects, which are manageable within prescribed dosage limits.

• Market Positioning:

  • Seeks to fill gaps in acute pain management and nasal decongestion, competing with NSAID/paracetamol combinations and intranasal decongestants like oxymetazoline.

What is the market size and growth projection?

The combined market for NSAIDs and nasal decongestants remains sizable:

Market Segment	2022 Valuation	2028 Projection	CAGR (2023-2028)
NSAID Market	$13.5 billion	$17.8 billion	5.4%
Nasal Decongestants	$4.2 billion	$6.0 billion	7.2%

Source: Grand View Research, 2023.

The integration of combination drugs for pain and congestion is part of broader trends targeting enhanced efficacy and reduced polypharmacy.

What are the key regulatory and commercial considerations?

• Regulatory Pathways:

  • Likely to seek FDA approval via New Drug Application (NDA) after completion of pivotal trials.
  • EU approval may follow via decentralized procedures if prioritized in major markets.
  • Demonstrating additive or synergistic benefit over existing treatments is crucial.

• Intellectual Property:

  • Patents granted in key jurisdictions extend into the late 2030s, offering exclusivity.
  • Formulations claimed to enhance bioavailability and reduce side effects could extend patent protection.

• Commercial Strategy:

  • Potential partnerships with pharmaceutical firms specializing in analgesics and nasal therapies.
  • Focused marketing campaigns targeting hospitals, clinics, and pharmacies.
  • Price positioning aims at mid-tier pricing to balance access and profitability.

What are the projected market opportunities?

• Within five years of approval, sales are projected to reach $400 million annually.
• Key growth drivers:
  • Increasing prevalence of acute pain cases.
  • Rising demand for non-opioid analgesics.
  • Growing OTC market for nasal decongestants.
• Potential barriers include competition from established NSAID and decongestant brands and regulatory hurdles related to safety concerns, particularly regarding vasoconstriction.

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Key Takeaways

• Clinical trials mostly confirm efficacy in pain relief and nasal decongestion, with a manageable safety profile.
• The drug targets markets worth over $20 billion, with steady growth driven by consumer demand for non-opioid pain relief and nasal therapies.
• Regulatory approval hinges on demonstrating clear benefit over existing treatments.
• Strategic partnerships and patent protections will shape commercialization pathways.
• Sales projections anticipate reaching hundreds of millions within five years post-approval.

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FAQs

1. When is regulatory approval expected?

Pending successful late-stage trial results, FDA submissions may occur within 18 months, with approval possible within 6-12 months thereafter.

2. What are the main competitors?

Existing analgesics like ketorolac alone, opioids, and combination NSAIDs; nasal decongestants such as oxymetazoline and phenylephrine-based sprays.

3. Are there any safety concerns?

Vasoconstriction associated with phenylephrine may pose cardiovascular risks in susceptible populations. NSAID-related gastrointestinal issues are also considered.

4. Is the drug available in over-the-counter formulations?

Currently in clinical trials, OTC availability will depend on trial outcomes and regulatory decisions.

5. What are the intellectual property rights?

Patents extend into the late 2030s, covering formulations, delivery methods, and specific combinations, providing a competitive patent position.

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References

1. ClinicalTrials.gov. "Ketorolac Tromethamine and Phenylephrine Hydrochloride Trials." 2023.
2. Grand View Research. "Analgesics and Decongestants Market Analysis." 2023.
3. U.S. FDA. "Guidance on Combination Drug Approvals." 2022.
4. European Medicines Agency. "Evaluation Procedures for Nasal Decongestants." 2022.
5. Industry Reports. "Market Trends in Acute Pain and Nasal Therapies." 2022.