Trial reportBritish journal of clinical pharmacology2017
Pharmacokinetics and pharmacodynamics of a new highly concentrated intranasal midazolam formulation for conscious sedation.
Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed.
- Fit for purpose of on-the-road driving and simulated driving: A randomised crossover study using the effect of sleep deprivation.PloS one · 2023Trial
- Trial
- Pharmacokinetics and pharmacodynamics of a new highly concentrated intranasal midazolam formulation for conscious sedation.British journal of clinical pharmacology · 2017Trial
- Comparative evaluation of the effectiveness and acceptance of intranasal dexmedetomidine and intranasal midazolam for sedation in children aged 5-8 years using a mucosal atomizer device: a randomized controlled clinical study.Journal of dental anesthesia and pain medicine · 2025Article
- Treatment of agitation in terminally ill patients with intranasal midazolam versus subcutaneous midazolam: study protocol for a randomised controlled open-label monocentric trial (MinTU Study).BMC palliative care · 2024Article
- Genetic polymorphisms are associated with individual susceptibility to dexmedetomidine.Frontiers in genetics · 2023Article
- Perioperative Low Dose Dexmedetomidine and Its Effect on the Visibility of the Surgical Field for Middle Ear Microsurgery: A Randomised Controlled Trial.Frontiers in pharmacology · 2022Article
- Amnesia after Midazolam and Ketamine Sedation in Children: A Secondary Analysis of a Randomized Controlled Trial.Journal of clinical medicine · 2021Article
- A Physiologically Based Pharmacokinetic Model for Predicting Diazepam Pharmacokinetics after Intravenous, Oral, Intranasal, and Rectal Applications.Pharmaceutics · 2021Article
- Overcoming the challenges of developing an intranasal diazepam rescue therapy for the treatment of seizure clusters.Epilepsia · 2021Article
- First-line management of canine status epilepticus at home and in hospital-opportunities and limitations of the various administration routes of benzodiazepines.BMC veterinary research · 2021Review
- A Short Review on the Intranasal Delivery of Diazepam for Treating Acute Repetitive Seizures.Pharmaceutics · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimTo evaluate the pharmacokinetics, pharmacodynamics, nasal tolerance and effects on sedation of a highly concentrated aqueous intranasal midazolam formulation (Nazolam) and to compare these to intravenous midazolam.
methodsIn this four-way crossover, double-blind, double-dummy, randomized, placebo-controlled study, 16 subjects received 2.5 mg Nazolam, 5.0 mg Nazolam, 2.5 mg intravenous midazolam or placebo on different occasions. Pharmacokinetics of midazolam and α-hydroxy-midazolam were characterized and related to outcome variables for sedation (saccadic peak velocity, the Bond and Lader visual analogue scale for sedation, the simple reaction time task and the observer's assessment of alertness/sedation). Nasal tolerance was evaluated through subject reporting, and ear, nose and throat examination.
resultsNazolam bioavailability was 75%. Maximal plasma concentrations of 31 ng ml
conclusionsThis study demonstrates the nasal tolerance, safety and efficacy of Nazolam. When considering the preparation time needed for obtaining venous access, conscious sedation can be achieved in the same time span as needed for intravenous midazolam. Nazolam may offer important advantages in conscious sedation.
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