This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:
Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)
Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups.
the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events

Start Date01 Apr 2024

Sponsor / Collaborator

Alexandria University

NCT06196580 / CompletedPhase 1

A Clinical Study Evaluating the Pharmacokinetic Effects of SHR4640 on Repaglinide and Midazolam in Healthy Subjects and the Impact of SHR4640 on QT Interval

The purpose of this study is to evaluate the PK effects of SHR4640 tablets on repaglinide and midazolam, as well as the effects of SHR4640 tablets on the QT interval in healthy subjects.

Start Date04 Jan 2024

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

CTIS2023-504903-10-00 / Not yet recruiting

- LESVIBUCCO/23/BQ-3

Start Date16 Aug 2023

Sponsor / Collaborator

Laboratorios Lesvi SL

100 Clinical Results associated with Midazolam Hydrochloride

100 Translational Medicine associated with Midazolam Hydrochloride

100 Patents (Medical) associated with Midazolam Hydrochloride

133

Literatures (Medical) associated with Midazolam Hydrochloride

01 Apr 2023·Minerva anestesiologica

Efficacy and safety of oral versus intranasal midazolam as premedication in children: a systematic review and meta-analysis

Review

Author: Lang, Bingchen ; Wu, Lan ; Chen, Shouming ; Zhang, Wensheng

INTRODUCTION:

Midazolam hydrochloride is a widely accepted benzodiazepine for premedication in pediatric patients. However, there is no consistent conclusion regarding which route of administration is best. We performed a meta-analysis to assess the efficacy and safety of oral versus intranasal midazolam premedication in children.

EVIDENCE ACQUISITION:

The PubMed, Embase, Cochrane Library, and Google Scholar databases were searched from inception to June 2022, for randomized controlled trials comparing oral versus intranasal midazolam. Primary outcomes included satisfactory mask acceptance for induction and satisfactory sedation at separation from parents. Secondary outcomes included the incidence of postoperative nausea and vomiting, incidence of nasal irritation, postoperative recovery time, and hemodynamic changes.

EVIDENCE SYNTHESIS:

Data from 14 studies involving a total of 901 children were obtained. The results indicated that intranasal and oral midazolam premedication in children provided similar satisfactory mask acceptance for induction (RR, 1.02; 95% CI, 0.93-1.13; P=0.64; I²=0%), satisfactory sedation at separation from parents (RR, 0.99; 95% CI, 0.89-1.10; P=0.90; I²=57%), and postoperative recovery time (WMD, -8.01; 95% CI, -20.16-4.14; P=0.20; I²=85%). Additionally, intranasal midazolam premedication was associated with lower incidence of postoperative nausea and vomiting (RR, 0.70; 95% CI, 0.51-0.96; P=0.03; I2=0%) and shorter onset time.

CONCLUSIONS:

Differences between intranasal and oral midazolam in satisfactory mask acceptance for induction, satisfactory sedation at separation from parents, and postoperative recovery time were not significant. Intranasal midazolam premedication was associated with shorter onset time and higher incidence of nasal irritation.

01 Aug 2021·Epilepsy researchQ3 · MEDICINE

A Phase 3 open-label study of the efficacy, safety and pharmacokinetics of buccally administered midazolam hydrochloride for the treatment of status epilepticus in pediatric Japanese subjects

Q3 · MEDICINE

Article

Author: Takeda, Shinichi ; Fournier, Martha ; Yoshinaga, Harumi ; Kugler, Alan R ; Benitez, Arturo

BACKGROUND:

In Japan, intravenous (IV) administration of antiepileptic drugs in a healthcare setting is the preferred treatment option that is both licensed and recommended for initial treatment of status epilepticus (SE). However, prompt conveyance to a healthcare institution and IV access may be difficult in patients experiencing a seizure and so delay treatment. Thus, there is an unmet need for an alternative effective antiepileptic drug with an easier and more rapid mode of administration. In this study we evaluated a midazolam hydrochloride oromucosal solution (MHOS) that can be simply and rapidly administered to patients in SE.

METHODS:

A Phase 3, interventional, multicenter, nonrandomized study was conducted in 28 clinical centers in Japan. Pediatric subjects in convulsive SE received treatment with buccal MHOS with dosage based on their age. The primary efficacy outcome was the percentage of subjects with seizure termination within 10 min and a 30-min absence of visible seizure activity from time of administration. Safety evaluations included respiratory depression and the frequency of treatment-emergent adverse events (TEAEs). Pharmacokinetic (PK) profile was also assessed.

RESULTS:

The study population comprised 25 subjects with a median age of 2.8 years and median bodyweight of 13.4 kg. The primary efficacy outcome was achieved in 80 % of subjects; 84 % of subjects had seizure resolution within 10 min. Nine subjects experienced a total of 13 TEAEs, and protocol-defined respiratory depression occurred in one subject. Mean maximum plasma midazolam concentration was 78.0 ng/mL, and mean time to peak concentration was 20.5 min, demonstrating that achieving maximum plasma midazolam concentration is not required for seizure cessation.

CONCLUSIONS:

The efficacy, safety and pharmacokinetic profile of MHOS in pediatric Japanese subjects was consistent with that observed in non-Japanese populations. Compared to IV treatments, MHOS offers easier administration which may reduce the time to treatment and thereby minimize the sequelae of prolonged seizures.

01 May 2021·Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility SocietyQ3 · MEDICINE

Same‐day opioid administration in opiate naïve patients is not associated with opioid‐induced esophageal dysfunction (OIED)

Q3 · MEDICINE

Article

Author: Katzka, David A. ; Alexander, Jeffrey A. ; Balko, Ryan A. ; Murray, Joseph A. ; Ravi, Karthik ; Mara, Kristin C.

Abstract:

Background:

Opioid‐induced esophageal dysfunction (OIED) is a recognized complication of chronic opioid use. However, the impact of acute opioid administration on esophageal motility remains unclear.

Methods:

Opioid naïve patients with high‐resolution manometry (HRM) <480 min following esophagogastroduodenoscopy (EGD) (opioid‐HRM) and a control group with HRM <36 h prior to EGD between January 1, 2016, and November 10, 2018, from a single institution were identified. EGDs were performed exclusively with versed and fentanyl.

Key Results:

One hundred and seventy‐four patients were identified, with 83 (47.7%) opioid‐HRM and 91 (52.3%) controls. Mean time from EGD to HRM was 229 (78–435) min. Baseline clinical features and HRM indications were similar between opioid‐HRM and controls. Chicago classification v3.0 defined HRM findings were similar between groups. Major motility disorders as defined by the Chicago classification v3.0 occurred at a similar frequency among opioid‐HRM and controls (27.7% vs. 36.3%, p = 0.23). Mean distal contractile integrity (DCI) was higher in opioid‐HRM (1939.3 ± 1318.9 vs. 1792.2 ± 2062.3 mmHg∙cm∙s, p = 0.043), but maximum DCI, distal latency, and integrated relaxation pressure did not differ between groups. Subgroup analysis assessing time and dose dependency did not identify differences in individual manometric parameters and Chicago classification v3.0 diagnosis between patients with HRM <240 min after EGD, >240 min after EGD, ≥125 mcg of IV fentanyl, <125 mcg IV fentanyl and controls.

Conclusions and Inferences:

Same‐day acute opioid administration did not affect HRM findings in opioid naïve patients. Studies assessing the pathophysiology of and duration‐dependent relationship with opioids in OIED are needed.

News (Medical) associated with Midazolam Hydrochloride

07 Dec 2022

·www.prnewswire.com

Neuraxpharm expands into the Netherlands

The CNS specialist continues its strong expansion course in Europe and increases its presence from two to 20 countries in just six years NAARDEN, Netherlands and DÜSSELDORF, Germany, Dec. 7, 2022 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces the establishment of Neuraxpharm Netherlands. The expansion into the Dutch market allows Neuraxpharm to continue on its pathway to become the number one CNS specialist in Europe. Neuraxpharm Netherlands will provide differentiated and specialty generics in the Netherlands, a strategically important CNS pharmaceutical market in Europe. To date, Neuraxpharm Netherlands has launched two products: Dimethyl Fumarate to treat multiple sclerosis and Lacosamide, a product for the treatment of epileptic seizures. In addition, the company plans to launch Rivastagmin for treating dementia, which will become Neuraxpharm's third product in the Netherlands. The subsidiary will be run by Philipp Pohoralek as Country Manager for Neuraxpharm Netherlands, alongside his current role as Country Manager for Neuraxpharm Germany. As an experienced executive, Philipp will strive to strengthen the company's growth strategy in the Netherlands in line with his achievements in the important German market, which is the third largest CNS-market globally. Neuraxpharm Netherlands will conduct its operations from Naarden. Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, said: "By entering the Dutch market Neuraxpharm continues its strong growth momentum. We aim to become a leader in the Dutch CNS field, offering high value-added solutions to our stakeholders and patients. Our aim for 2023 is to further strengthen our portfolio pipeline in the Netherlands and to expand our dedicated team." Philipp Pohoralek, Country Manager of Neuraxpharm Netherlands, added: "We will leverage our CNS expertise to provide CNS patients, physicians, pharmacists and hospitals throughout the Netherlands with access to suitable products from our extensive portfolio thereby catering to the needs of patients in the region. We will furthermore provide a tailor-made entry out of more than 120 CNS molecules." Neuraxpharm is a European key player in the CNS market with a presence in more than 60 countries. With over 35 years of experience in the CNS field, the company has acquired a unique expertise in this market developing and commercializing established brands, value-added medicines, generics, Consumer Health products, medical cannabis, digital health solutions and orphan drugs. Neuraxpharm distributes its products through an extensive sales force in Europe. The company has a research hub and produces many of its products at its two production sites in Europe. In 2022, Neuraxpharm reached over 1000 employees. The recent market entry into the Netherlands follows a strong track-record. In the past few months Neuraxpharm has reached several milestones including entering the Greek CNS market and the steady expansion of its product offering through acquisitions, including two established product portfolios of branded business from Sanofi and prescription brand, Buccolam® (midazolam), in 2020, which is indicated for the emergency treatment of children and adolescents with epileptic seizures. In addition, Neuraxpharm has leveraged new business opportunities by entering the digital health and orphan drug markets through new licensing agreements with mjn-SERAS and Minoryx. Finally, the company has reinforced its position as a key player in the European medical cannabis market by creating a business unit dedicated to medical cannabis and expanding its collaboration with Panaxia, a global manufacturer of advanced medical cannabis products, into Switzerland and the Czech Republic. About the Group Neuraxpharm Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of central nervous system disorders (CNS) with a direct presence in 20 countries. Backed by funds advised by Permira, Neuraxpharm has a unique understanding of the CNS market built over 35 years. With its focus on CNS, Neuraxpharm develops and commercializes established brands, value added medicines, generics, Consumer Healthcare products, medical cannabis, beyond-the-pill solutions (digital health and medical devices) and orphan drugs and is continuously striving to offer a wide range of effective, high quality and affordable CNS treatment options in Europe. Present with its products in more than 60 countries, Neuraxpharm also manufactures pharmaceutical products and active pharmaceutical ingredients in its own manufacturing sites, Lesvi and Inke, in Spain. For more information, please visit SOURCE Neuraxpharm

License out/inExecutive ChangeDrug ApprovalOrphan Drug

25 Feb 2020

·www.primexpharma.com

OZALIN® continues to receive marketing authorization approvals across EU

Zug, 25th February 2020, Swiss company Primex Pharmaceuticals announces it has received international approval of the repeat use procedure for OZALIN® (ADV6209) involving the following 8 countries: Germany, Austria, Spain, Portugal, Ireland, Belgium, Greece and Poland. This follows the decentralised regulatory approval and marketing authorization approval in France, UK, Italy, Netherlands, Finland, Norway and Denmark at the end of 2018 for children from 6 months to 17 years for moderate sedation before therapeutic or diagnostic procedures, and as premedication prior to anaesthesia. OZALIN is commercialized in the above countries. Alan Knox, CEO of Primex, comments: “This is another milestone for Primex in paediatric anaesthesia. This will allow us to expand the availability of OZALIN across Europe. Initially developed by Amiens Hospital in France, very few companies are developing medicines in paediatric anaesthesia and we are happy to offer a palatable oral solution developed by clinicians for children’s needs. The sales potential is over 100 million euros in Europe alone, but more importantly, we can really make a difference here.” For further information, please contact: Primex Pharmaceuticals AG Mr. Alan Knox, Group CEO Mobile : +41 791762420 Email : alan.knox@primexpharma.com About Primex Pharmaceuticals : Primex Pharmaceuticals is a leading global innovative anaesthesia company, expanding in paediatric pharmaceuticals. Primex brings a portfolio of anaesthesia products helping patients undergo a wide range of medical procedures, including a novel, oral solution for paediatric sedation now approved in several markets in the European Union. Primex Pharmaceuticals will continue to identify and bring to the market new medications that complete the Triad of Anaesthesia. Primex Pharmaceuticals is headquartered in Switzerland. For further information, please visit www.primexpharma.com © Primex Pharmaceuticals AG, Zug, Switzerland. All rights reserved OZALIN® is called OZASED® in some countries

Drug Approval

100 Deals associated with Midazolam Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00696	Midazolam Hydrochloride	N05CD08	DB00683

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Status Epilepticus	US	Meridian Medical Technologies LLC	14 Sep 2018
Seizures	EU	Neuraxpharm Pharmaceuticals S.L.	04 Sep 2011
Seizures	IS	Neuraxpharm Pharmaceuticals S.L.	04 Sep 2011
Seizures	LI	Neuraxpharm Pharmaceuticals S.L.	04 Sep 2011
Seizures	NO	Neuraxpharm Pharmaceuticals S.L.	04 Sep 2011
Anesthesia	US	Hoffmann-La Roche, Inc.	20 Dec 1985
Sedation	US	Hoffmann-La Roche, Inc.	20 Dec 1985

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03336450 (CTgov)	Phase 3	Status Epilepticus	3	MHOS/SHP615	bkcwrtwoep(hyfgmvetfh) = myiuhouzuo bjwnqzjeie (qdmgcxsike, qurplwlrco - sqlefitkfi) View more	-	14 Sep 2021
NCT03336645 (CTgov)	Phase 3	Status Epilepticus	25	SHP615	qhhdzdaytn(rxvskpupww) = fbapsxazbn vpegzjzlln (nkwixbrkph, onipjwggnw - gvwbbwrdtv) View more	-	31 Jul 2020
NCT02419547 (CTgov)	Not Applicable	Tachycardia, Ventricular	11	Versed+propofol+Sevoflurane+fentanyl	esmhhzljny(hgvmdysfcl) = ahopsevcvc oewczyukvt (knkslchyqv, dpqakcxklp - urgvypojrm) View more	-	09 Oct 2019
NCT01315158 (CTgov)	Not Applicable	Sleep Apnea, Obstructive \| Sedation \| Obesity	36	Versed+Propofol+Fentanyl (Propofol+Benzo/Opioids)	mwygekichj(jrehkpwsmk) = glgweapkyq uhroiygyic (wtukzcxwbc, zoxdiivezf - lbnkvzpxce) View more	-	28 Oct 2016
NCT01315158 (CTgov)	Not Applicable	Sleep Apnea, Obstructive \| Sedation \| Obesity	36	Propofol Alone (Propofol Alone)	mwygekichj(jrehkpwsmk) = sktmutgxxx uhroiygyic (wtukzcxwbc, qtormiawiw - xdvzjuprnr) View more	-	28 Oct 2016

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