Midazolam Hydrochloride: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Midazolam Hydrochloride appears in the FDA drug-label database. Marketed as Midazolam.
- Boxed warning
- The FDA label for Midazolam Hydrochloride carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Midazolam injection is indicated: intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. — Fresenius Kabi USA, LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2012-09-27 |
| Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL — Fresenius Kabi USA, LLC | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2017-10-27 |
| Failed Impurities/Degradation Specifications — Fresenius Kabi USA, LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2016-12-16 |
Phase breakdown
Conditions being studied
Recruiting trials involving Midazolam Hydrochloride
- Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)
- Ketamine for Combined Depression and Alcohol Use Disorder
- i-CBT and IV Ketamine for Suicidality in Treatment-Resistant Depression: A Randomized, Midazolam-Controlled Clinical Trial
Common questions
Is Midazolam Hydrochloride FDA-approved?
Yes, marketed as Midazolam. Its FDA label carries a boxed warning.
How many recruiting trials involve Midazolam Hydrochloride?
3 recruiting trials across 13 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.