CLINICAL TRIALS PROFILE FOR KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

All Clinical Trials for KETOROLAC TROMETHAMINE; 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; PHENYLEPHRINE HYDROCHLORIDE

Condition Name

Condition Name for KETOROLAC TROMETHAMINE; 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; PHENYLEPHRINE HYDROCHLORIDE
Intervention	Trials

Clinical Trial Locations for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Trials by Country

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

Clinical Trial Progress for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE

Sponsor Name

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

Sponsor Type

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

Ketorolac Tromethamine + Phenylephrine Hydrochloride: Clinical-Stage Update, Market Read-Through, and Forecast

Last updated: May 4, 2026

What combination is this and what product position does it imply?

Ketorolac tromethamine plus phenylephrine hydrochloride is a fixed-dose ophthalmic combination used to reduce ocular pain and inflammation while constricting conjunctival vessels to address hyperemia/redness. The two active ingredients map to distinct pharmacologic roles:

• Ketorolac tromethamine: NSAID; inhibits cyclooxygenase pathways to reduce prostaglandin-mediated pain and inflammation.
• Phenylephrine hydrochloride: alpha-adrenergic agonist; causes vasoconstriction to reduce ocular redness.

In practical commercialization terms, this combination typically targets symptom control in post-procedural or episodic ocular irritation/pain settings where patients and clinicians want rapid reduction in pain/inflammation and visible redness.

What is known about the clinical development status?

No verifiable, source-citable clinical trial registry entries, milestones, or sponsor updates for ketorolac tromethamine + phenylephrine hydrochloride as a fixed combination are provided in the input. Without registries, publications, sponsor press releases, or regulatory filings to cite, a complete and accurate “clinical trials update” for this exact combination cannot be produced.

What does the available evidence imply for market dynamics?

Given the lack of citable combination-specific trial data here, the most defensible market read-through is to anchor expectations in the established commercialization patterns of ophthalmic pain/inflammation control plus decongestion (NSAID + vasoconstrictor class).

Demand drivers

• Procedural volume: Any market where ophthalmic procedures drive short-course pain and hyperemia management creates demand for combination ophthalmic drops.
• Patient adherence: Fixed combinations can reduce dosing complexity versus separate bottles (a real driver in short-duration peri-procedural use).
• Switching costs: Once a clinician uses a protocolized set of drops, switching depends on perceived efficacy and tolerability.

Competitive pressure

• Class competition: Ophthalmic NSAIDs (alone) compete on pain/inflammation control; vasoconstrictors (alone) compete on redness.
• Formulation competition: Preservative systems, dosing frequency, and sterility/packaging can outperform efficacy claims at the margins if tolerability is strong.

Pricing and channel

• Ophthalmic products typically sell through retail and specialty channels depending on indication and reimbursement dynamics. For combination symptom packs, payer behavior and clinician preference matter more than blockbuster-scale distribution economics.

What does this mean for a forecast?

A credible forecast requires baseline commercial data (current sales, unit share, channel mix), trial/label specifics (indication, line of therapy, dosing duration), and regulatory timelines. The input does not include those items. Under the operating constraints, a complete and accurate projection cannot be produced.

Where can ketorolac + phenylephrine fit in a real-world label landscape?

The combination’s pharmacology supports positioning in one or more of these label archetypes:

• Post-procedural pain/inflammation with redness: Short-course therapy after ocular interventions.
• Acute ocular irritation where redness and pain co-occur.
• Symptom management protocols in ophthalmology offices.

The exact approved indication(s), dosing schedule, and contraindications determine TAM by patient population and duration of use. None are provided in the input and none can be substituted without citations.

Market sizing framework (what a forecast would require, and why it cannot be filled here)

To project revenue for ketorolac tromethamine + phenylephrine, a standard model uses:

1. Indication population

• Number of eligible patients per year by geography.
• Expected utilization rate (drops per course, number of courses).

2. Efficacy/tolerability positioning

• Clinical endpoints tied to label claims.
• Relative performance vs monotherapies.

3. Pricing and reimbursement

• Average net price (after rebates) by channel.
• Coverage and formulary status.

4. Share dynamics

• Adoption ramp (conversion from existing protocols).
• Competition response (generic pressure, label carve-outs).

Since the input provides none of these concrete values for this exact combination, any numeric market projection would be unsupported.

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Key Takeaways

• Clinical update: A source-citable combination-specific trial status cannot be produced from the provided input.
• Market analysis: The combination’s market role aligns with short-course ophthalmic pain/inflammation control plus reduction of redness, but no label, uptake, or competitor performance data is provided to anchor a forecast.
• Projection: A complete and accurate revenue forecast cannot be generated without indication-specific label data, baseline sales/share, and trial/regulatory timelines.

FAQs

1. Is ketorolac tromethamine + phenylephrine hydrochloride a widely used fixed ophthalmic combination?
   The combination’s pharmacologic intent is consistent with common ophthalmic symptom-management needs, but usage breadth and adoption depend on the specific marketed product and label.

2. What clinical endpoints matter most for this combination?
   For the NSAID component: pain and inflammation reduction; for the phenylephrine component: ocular hyperemia/redness reduction and tolerability.

3. How does a fixed combination compete against monotherapies?
   It competes on regimen simplicity and perceived overall symptom coverage, balanced against tolerability and packaging/dosing.

4. What drives short-course ophthalmic uptake?
   Clinician protocolization, perceived efficacy in real-world settings, and regimen convenience.

5. What is required for an investable market projection?
   Indication-specific label population, dosing/course assumptions, net pricing by channel, adoption ramp, and competitive response.

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References

[1] (No cited sources were provided in the input; no source-citable clinical or regulatory details for the fixed combination are available to cite.)