Last Updated: May 30, 2026

CLINICAL TRIALS PROFILE FOR MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE


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All Clinical Trials for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01055236 ↗ Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients Completed Mahidol University Phase 4 2007-08-01 Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects Hydroxyzine should be used in the prevention of these symptoms.
NCT01236859 ↗ Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus Completed Prince of Songkla University N/A 2009-09-01 Intrathecal morphine provides good postoperative analgesia for up to 18-24 hour after administration. Pruritus is the most common side effect of intrathecal morphine, which the incidence was reported as 20%-100%2 and 63% in Songklanagarind Hospital. Pathophysiology of opioid-induced pruritus remain unclear and more than one mechanism may be involved in the development of opioid-induced pruritus, such as, mediated central µ opioid receptors, Dopamine (D2) receptors, Serotonin (5-HT3) receptors, prostaglandin system, GABA receptors, and glycine receptors, so that why opioid-induced pruritus is difficult to manage. Many medications have been used to treat this side effect included antihistamines, 5-HT3 (serotonin) receptor antagonists, opioid antagonists, opioid agonist-antagonists, propofol, and nonsteroidal antiinflammatory drugs. Gabapentin is an anticonvulsant, a structural analog of aminobutyric acid, and currently approved by the Food and Drug Administration for the treatment of partial seizures and postherpetic neuralgia. Many studies have shown gabapentin to be effective in the case of brachioradial pruritus, itch of neuropathic in origin, uremic pruritus, multiple sclerosis-induced pruritus,cholestatic pruritus, itch produced by burn, and pruritus of unknown origin. However, there is only one small study in Taiwan shown the effectiveness of gabapentin 1200 mg in prevention of intrathecal morphine-induced pruritus in orthopedic surgery, which could reduce incidence of pruritus from 77.5% to 47.5% (38.7% reduction). Because gabapentin has several side effects especially in high dose such as drowsiness, dry mouth, headache, unsteadiness, reduced co-ordination or slowed reaction, constipation, diarrhea, peripheral edema, dizziness, confusion, loss of concentration, weight gain, and nausea, vomiting, so in our study we decided to reduce the dose of gabapentin. Therefore, we would like to know if gabapentin in a smaller dose (600 mg) used in the wider range of age including the elderly can decrease the incidence of intrathecal morphine-induced pruritus in orthopedic surgery in Songklanagarind Hospital.
NCT01404442 ↗ Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section Completed Qazvin University Of Medical Sciences Phase 1/Phase 2 2011-05-01 Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an additive to bupivacaine in patients undergoing cesarean section . Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia [Saturation of peripheral oxygen (SpO2)4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.
NCT01971645 ↗ Decadron as Adjuvant in Femoral Nerve Blocks in Knee Arthroscopy Completed Nationwide Children's Hospital Phase 3 2014-07-01 If preservative-free dexamethasone 0.1 mg/kg (max dose 4 mg) is added to ropivacaine 0.5% 2 mg/kg (max dose 100 mg), then post-PACU opioid consumption will be reduced by 33%.
NCT02825056 ↗ Postoperative Hemodynamics Comparison After High Spinal Block With or Without Intrathecal Morphine. Unknown status Postgraduate Institute of Medical Education and Research Early Phase 1 2016-07-01 There is paucity of literature on the effects of intrathecal morphine on the postoperative hemodynamics in the cardiac-surgical patients.We planned this study to compare the post-operative hemodynamic effects (particularly the incidence of vasoplegia in the two study groups) and outcome of combined general anesthesia + high spinal block, with or without intrathecal morphine in patients undergoing cardiac-surgical procedures in our set up.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Condition Name

Condition Name for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Intervention Trials
Pruritus 3
Pain 1
Hip Arthroscopy 1
Pain Management 1
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Condition MeSH

Condition MeSH for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Intervention Trials
Pruritus 3
Pain, Postoperative 2
Vomiting 2
Nausea 2
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Clinical Trial Locations for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Trials by Country

Trials by Country for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Location Trials
United States 15
Egypt 3
Thailand 2
Saudi Arabia 1
Iran, Islamic Republic of 1
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Trials by US State

Trials by US State for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Location Trials
Virginia 2
Pennsylvania 2
Ohio 2
West Virginia 1
Texas 1
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Clinical Trial Progress for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Clinical Trial Phase

Clinical Trial Phase for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Clinical Trial Phase Trials
PHASE4 1
Phase 4 4
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Clinical Trial Phase Trials
Completed 12
Unknown status 1
Not yet recruiting 1
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Clinical Trial Sponsors for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Sponsor Name

Sponsor Name for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Sponsor Trials
University of Pennsylvania 2
Nashwa Ahmed 1
Nationwide Children's Hospital 1
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Sponsor Type

Sponsor Type for MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
Sponsor Trials
Other 14
Industry 1
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Midazolam Hydrochloride Preservative-Free Clinical Trials Update and Market Projection (2026-2035)

Last updated: May 21, 2026

Midazolam hydrochloride preservative-free (PF) is a niche parenteral product used for procedural sedation and anesthesia workflows where preservative content is clinically undesirable (notably neonatal, pediatrics, and certain ICU/airway scenarios). Public information supports ongoing launches and label-supporting studies for sedation safety, pharmacokinetics (PK), and administration protocols, but it is not possible to produce a complete, accurate, patent-anchored clinical and market projection for this specific drug variant from the provided context.

Clinical trials for midazolam hydrochloride preservative-free: What studies are recruiting, completed, or reporting results?

Featured snippet answer: Without authoritative trial identifiers (NCT numbers), study design details, and reporting dates specific to the preservative-free formulation, a precise trial-by-trial update cannot be produced.

What endpoints matter most for preservative-free midazolam in sedation and anesthesia trials?

Key endpoint clusters typically include:

  • Time to sedation onset (procedural sedation)
  • Sedation depth measures (e.g., MOAA/S or similar scales)
  • Safety events: respiratory depression, hypotension, need for reversal agents
  • PK parameters: Cmax, Tmax, AUC, half-life
  • Re-dosing intervals and cumulative exposure
  • Compatibility and stability in common infusion/administration systems

Which populations are most relevant to preservative-free formulations?

  • Neonates and infants (preservative exposure considerations)
  • Pediatrics requiring procedural sedation
  • ICU and perioperative patients where administration route and dilution matter

What dosing routes are typically studied for midazolam PF?

  • Intravenous bolus or IV titration
  • Intravenous infusion
  • Premedication workflows in procedural and perioperative settings

How big is the market for midazolam hydrochloride preservative-free, and where does demand come from?

Featured snippet answer: A quantified market size, segment split, and demand drivers cannot be produced accurately for this exact formulation without product-level commercialization identifiers and inventory-level supply data.

Demand drivers

  • Procedural sedation volumes (endoscopy, radiology, dentistry)
  • Perioperative anesthesia utilization
  • Neonatal and pediatric hospital formularies and sedation protocols
  • ICU sedation continuity and protocol standardization
  • Substitution away from preservative-containing options in targeted settings

Cost and procurement dynamics

  • Tenders typically select by formulary access, supply reliability, and total acquisition cost
  • Unit pricing is highly sensitive to manufacturing capacity and shortages
  • Hospital procurement often bundles sedation supplies by distributor and volume commitments

Competitive substitution risk

  • Hospitals may switch between midazolam presentations (PF vs non-PF) based on availability and clinical policy
  • If PF supply becomes constrained, clinicians may accept alternatives depending on institutional standards

What is the clinical and commercial outlook for preservative-free midazolam through 2030?

Featured snippet answer: A time-phased projection requires baseline unit volumes and documented formulation-level utilization, which cannot be established from the provided context.

Pricing pressure and reimbursement

  • Generic midazolam products generally face margin pressure
  • Budget impact often determines adoption, especially in systems with centralized purchasing

Supply stability and manufacturing scale

  • Sterile injectables are susceptible to batch-level disruptions
  • Any consolidation at the sterile manufacturing tier can swing availability quickly

Regulatory and label evolution

  • Updated label language around pediatric use, sedation protocols, and safety monitoring can affect guideline adoption
  • Any preservative-free-specific labeling could increase demand in pediatric-heavy systems

When will midazolam hydrochloride preservative-free face major generic or biosimilar substitution risks?

Featured snippet answer: A launch-risk calendar cannot be produced without the specific NDA/ANDA/BLA and the Orange Book record for this formulation.

What usually drives entry timing for sterile sedatives

  • ANDA approval dates for specific strengths and pack sizes
  • Patent expirations covering formulation, manufacturing, and method-of-use
  • Pediatric exclusivity, if any, tied to the original approval
  • Exclusivity that blocks ANDA approval for the same active moiety and route

Where Paragraph IV challenges typically show up

  • Process patents (sterile filling, stability)
  • Formulation patents (solubilizers, pH targets, excipient set)
  • Delivery-related packaging or stability claims

How does preservative-free midazolam compare with alternative midazolam presentations on safety, onset, and handling?

Featured snippet answer: Preservative-free variants primarily differ in excipient formulation and compatibility considerations; PK and clinical efficacy typically remain broadly consistent for the same active moiety under equivalent dosing, but real-world adoption depends on hospital policy and administration workflows.

Safety considerations most likely to be formulation-sensitive

  • Excipient exposure concerns in neonates and infants
  • Tolerability with repeated administration
  • Local tissue effects associated with specific diluents and pH windows

Handling and administration

  • Stability in syringes and admixture workflows
  • Compatibility with IV lines and common infusion diluents
  • Shelf-life and “in-use” time constraints that affect ward workflow

Practical switching behavior

  • If PF stock-outs occur, hospitals may revert to non-PF with policy-based risk assessments
  • Adoption is strongest where pediatric sedation protocols explicitly require PF

What is the FDA status of midazolam hydrochloride preservative-free (Orange Book and labeling)?

Featured snippet answer: FDA status, Orange Book listings, and patent coverage for the preservative-free variant cannot be established from the provided context.

What to look for in the Orange Book for this product class

  • Drug product listing by strength, dosage form, and manufacturer
  • Approval pathway (NDA vs ANDA)
  • Listed patents: composition of matter vs formulation vs method-of-use vs process
  • Patent-expiry and exclusivity blocks by reference product

Label content items that matter for clinical adoption

  • Indications: sedation in adults and pediatric patients (as specified)
  • Pediatric dosing language and monitoring requirements
  • Warnings: respiratory depression, hypotension, drug interactions, elderly/pediatric precautions
  • Administration instructions: titration guidance and monitoring

What patent estate protects midazolam hydrochloride preservative-free and how strong is it?

Featured snippet answer: Patent protection cannot be mapped to this specific formulation variant without Orange Book drug-product identifiers and patent numbers tied to the PF product.

Patent types that commonly constrain sterile sedative alternatives

  • Formulation patents (excipient set and concentration ranges)
  • Manufacturing and sterile filling process patents
  • Stability and compatibility patents tied to “in-use” limitations
  • Method-of-use patents for specific procedural sedation regimens

Litigation and settlement signals that affect entry timing

  • Paragraph IV settlement agreements often include “carve-outs” for strengths/pack sizes
  • Consent decrees can shift launch windows for follow-on products

Key takeaways

  • A precise clinical trials update for “midazolam hydrochloride preservative-free” requires product-specific trial identifiers and reporting dates tied to this formulation.
  • A defensible market size and forecast requires formulation-level commercialization identifiers, baseline unit utilization, and supply availability by strength and pack size.
  • A legal and regulatory launch-risk timeline requires the specific FDA product listing (NDC and Orange Book code), with associated patent and exclusivity data.
  • If these formulation-level identifiers are not provided, any quantified market projection or exclusivity/entry calendar would be incomplete.

FAQs

  1. Which NDCs correspond to midazolam hydrochloride preservative-free, and what are their FDA approval pathways?
  2. Are there pediatric-only clinical trials that specifically use preservative-free midazolam and compare outcomes to non-PF formulations?
  3. How do hospital sedation protocols decide between midazolam preservative-free and non-preservative-free products during supply shortages?
  4. What excipient or packaging parameters typically differentiate preservative-free midazolam from other midazolam injection products?
  5. What Orange Book patents are most commonly implicated in ANDA challenges for sterile injectable sedatives like midazolam?

References (APA)

No sources cited.

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