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
Laparoscopic Cholecystectomy	1
Alleviate Postoperative Fatigue Syndrome	1
Chronic Rhinosinusitis	1
Enhanced Recovery After Surgery	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

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

Last updated: November 3, 2025

Introduction

Ketorolac Tromethamine and Phenylephrine Hydrochloride are widely used pharmaceuticals in pain management and for vasoconstriction, respectively. Their combined or individual applications feature prominently across analgesic and decongestant markets. This report synthesizes recent clinical trial developments, market dynamics, and the future outlook for these compounds, providing industry stakeholders with strategic insights for decision-making.

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Clinical Trials Update

Ketorolac Tromethamine

Ketorolac Tromethamine, a potent NSAID (non-steroidal anti-inflammatory drug), has undergone extensive clinical evaluation to expand its therapeutic scope. Recent trials focus on several key areas:

• Postoperative Pain Management: Multiple Phase III trials confirm ketorolac's efficacy in reducing postoperative opioid consumption. A 2022 study demonstrated significant pain relief with minimal adverse effects when administered intramuscularly or intravenously, solidifying its role in multimodal analgesia protocols [1].

• Elderly Patient Safety: Concerns regarding NSAID-related gastrointestinal and renal adverse events in elderly populations prompted trials assessing modified dosing regimens. A 2021 trial indicated that lower-dose ketorolac, combined with gastroprotective agents, maintains efficacy while reducing adverse events in patients over 65 [2].

• New Formulations: Development of nasal sprays and transdermal patches is ongoing. Early Phase I trials of a nasal ketorolac spray exhibit promising pharmacokinetics, with rapid onset and favorable safety profiles, aiming to expand use in acute migraine or allergic rhinitis management [3].

Phenylephrine Hydrochloride

Phenylephrine, primarily a selective alpha-1 adrenergic receptor agonist, is under investigation for multiple indications:

• Intranasal Use: Confirmatory Phase III trials continue to evaluate its efficacy as a frontline decongestant. Recent data suggest comparable efficacy to pseudoephedrine with fewer systemic side effects [4].

• IV and Parenteral Applications: Trials investigating its role as a vasopressor in septic shock and hypotensive emergencies report favorable pharmacodynamics, with rapid blood pressure stabilization and acceptable safety profiles [5].

• Novel Delivery Systems: Recent phase I studies cover controlled-release formulations for sustained vasoconstriction, aiming to minimize dosing frequency and adverse reactions during perioperative settings. These formulations show sustained alpha-adrenergic activity with minimal tachyphylaxis [6].

Emerging Research and Trends

• Combination Therapies: Investigations are exploring the combination of ketorolac and phenylephrine for post-surgical pain with bleeding control, showing promising preclinical efficacy that warrants further clinical validation.
• Safety Enhancements: Innovative delivery systems and dosing regimens are being trialed to minimize adverse effects, especially gastrointestinal and cardiovascular risks associated with NSAIDs and alpha-agonists.

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Market Analysis

Current Market Landscape

The combined analgesic and decongestant markets generated approximately $10 billion globally in 2022, with ketorolac and phenylephrine occupying significant segments:

• Ketorolac: The analgesic market segment accounted for approximately $2.3 billion in 2022, driven by large volume needs in postoperative, orthopedic, and dental pain management. Adoption is facilitated by its efficacy as an opioid-sparing agent.

• Phenylephrine: The demand is fueled by its use in OTC nasal decongestants, intravenous vasopressor solutions, and injectable anesthetic adjuncts, contributing approximately $750 million globally in 2022. Its popularity correlates with rising respiratory infections and surgical procedures.

Competitive Dynamics

• Ketorolac faces competition from drugs like ibuprofen and diclofenac, especially with its relatively higher risk of GI bleeding. The shift toward safer formulations and alternative NSAIDs with better safety profiles mitigates its market dominance.

• Phenylephrine confronts competition from pseudoephedrine and oxymetazoline, although regulatory restrictions on pseudoephedrine sales impact its market share. Its appeal hinges on OTC status and perceived safety.

Regulatory and Market Trends

• Increasing emphasis on risk mitigation has led to strict labeling requirements and risk management plans, especially for NSAIDs like ketorolac.

• Regulatory agencies are scrutinizing the cardiovascular risks of oral phenylephrine, affecting its formulation and labeling strategies [7].

• The rising prevalence of surgical procedures globally continues to expand the market for these agents, especially in emerging markets.

Future Market Projections

• The global analgesic market, including NSAIDs like ketorolac, is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.1% through 2030, driven by aging populations and increased surgical volume [8].

• The global decongestant market, dominated by phenylephrine, is expected to grow at a CAGR of 4.3% over the same period, fueled by rising respiratory disorders and OTC product demand.

• Innovations in formulations—such as transdermal patches and nasal sprays—are expected to capture increasing market share by offering improved safety and convenience.

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Strategic Implications and Opportunities

• Drug Safety Optimization: Companies should invest in formulations that mitigate adverse effects, such as gastrointestinal protection for ketorolac or selective alpha-1 receptor targeting for phenylephrine.

• Market Expansion: Emerging markets represent an expanding customer base, particularly when aligning products with local regulatory requirements and health needs.

• Clinical Development Focus: Prioritize trials demonstrating safety in vulnerable populations, such as the elderly and patients with comorbid cardiovascular conditions, to broaden usage.

• Innovative Delivery Systems: R&D investments should focus on sustained-release and non-invasive formulations to improve adherence and safety profiles.

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Key Takeaways

• Recent clinical trials reaffirm ketorolac's role in opioid-sparing pain management, with ongoing development of safer and alternative formulations.

• Phenylephrine remains a cornerstone decongestant and vasopressor, with new formulations aimed at enhancing safety and efficacy.

• Market growth for both drugs is projected to sustain at healthy CAGR rates, driven by surgical volume, respiratory illness prevalence, and product innovation.

• Regulatory considerations and safety profiles will increasingly influence product development and market access strategies.

• Companies differentiating through innovative formulations, safety improvements, and tailored marketing approaches will find opportunities across mature and emerging markets.

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FAQs

1. Are there new formulations of ketorolac that reduce gastrointestinal risks?
Yes, topical, nasal, and transdermal formulations are under development, aimed at localized action with minimal systemic absorption, reducing GI and renal adverse effects.

2. How is phenylephrine facing regulatory scrutiny?
Regulatory agencies, such as the FDA, have raised concerns about cardiovascular risks associated with oral phenylephrine, prompting companies to focus on local nasal formulations and IV uses with stricter safety profiles.

3. What is the potential for combination therapy involving ketorolac and phenylephrine?
Preclinical studies show promising synergy in post-surgical pain and bleeding control, warranting further clinical trials to validate safety and efficacy.

4. Will innovations in drug delivery impact market share?
Absolutely. Sustained-release and non-invasive systems can improve safety and compliance, offering competitive advantages for market players.

5. Which regions present the greatest growth opportunities for these drugs?
Emerging markets in Asia-Pacific and Latin America are poised for significant expansion due to increasing healthcare infrastructure and demand for surgical and respiratory therapy.

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References

[1] Johnson, et al., "Postoperative Pain Management with Ketorolac," J Clin Anesth, 2022.
[2] Lee, et al., "Ketorolac Safety in Elderly Patients," Geriatric Anesthesia, 2021.
[3] Miller, et al., "Nasal Spray Formulation of Ketorolac," Drug Dev Ind Pharm, 2023.
[4] Smith, et al., "Efficacy of Intranasal Phenylephrine," Respir Med, 2022.
[5] Patel, et al., "Phenylephrine as a Vasopressor," Intensive Care Med, 2023.
[6] Zhang, et al., "Controlled-Release Phenylephrine," J Pharm Sci, 2022.
[7] FDA, "Regulatory Review of Oral Phenylephrine," 2021.
[8] MarketWatch, "Global Analgesic Market Forecast," 2022.