Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients
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| ClinicalTrials.gov Identifier: NCT00290082 |
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Recruitment Status :
Terminated
(2 complications with midazolam)
First Posted : February 10, 2006
Last Update Posted : March 11, 2015
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Sponsor:
University Hospital, Rouen
Information provided by:
University Hospital, Rouen
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Brief Summary:
Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.
However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.
The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Agitated Patients | Drug: loxapine, midazolam Biological: blood sample Other: patient monitoring Drug: Loxapine Drug: Midazolam | Phase 3 |
Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Care Provider, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison Between Midazolam and Loxapine in the Treatment of Agitated Patients in the Emergency Department |
| Study Start Date : | December 2005 |
| Actual Primary Completion Date : | October 2007 |
| Actual Study Completion Date : | October 2007 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Loxapine
Loxapine succinate
Loxapine hydrochloride
Midazolam
Midazolam maleate
Midazolam hydrochloride
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: loxapine
agitated patients were randomly assigned either to loxapine, either to midazolam group
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Drug: loxapine, midazolam
agitated patients received loxapine 1 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 1 ml/ kg body weight ( midazolam 1mg/ml) if patients were still agitated 20 min after the first treatment, they received loxapine 0.5 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 0.5 ml/ kg body weight ( midazolam 1mg/ml)
Other Names:
Biological: blood sample
was evaluated in patients sedated, alcohol level, blood sugar
Other Names:
Other: patient monitoring
Till his coming out the emergency service, patient had an hemodynamic, respiratory and neurologic monitoring as well as an agitated score monitoring The occurence of a complication during the 15 days after leaving the emergency department was prospected.
Drug: Loxapine
Loxapine 1 mL / 10 kg
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Active Comparator: midazolam
midazolam is compared to loxapine in terms of efficacy and tolerance
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Drug: loxapine, midazolam
agitated patients received loxapine 1 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 1 ml/ kg body weight ( midazolam 1mg/ml) if patients were still agitated 20 min after the first treatment, they received loxapine 0.5 ml/ kg body weight ( loxapine 25mg/ml) or midazolam 0.5 ml/ kg body weight ( midazolam 1mg/ml)
Other Names:
Biological: blood sample
was evaluated in patients sedated, alcohol level, blood sugar
Other Names:
Other: patient monitoring
Till his coming out the emergency service, patient had an hemodynamic, respiratory and neurologic monitoring as well as an agitated score monitoring The occurence of a complication during the 15 days after leaving the emergency department was prospected.
Drug: Midazolam
Midazolam 1 mL / 10 Kg
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Primary Outcome Measures :
- Success of treatment at 20 min [ Time Frame: 20 min ]
Secondary Outcome Measures :
- Success of treatment at 40 and 60 min [ Time Frame: 40 and 60 mn ]
- Agitation level at 20,40 and 60 min [ Time Frame: 20, 40 and 60mn ]
- Need for rescue medication [ Time Frame: any time ]
- Sedation duration
- treatment failure [ Time Frame: one hour after treatment ]
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old
Exclusion Criteria:
Hypoglycemia hypoxemia patients with known dementia blood pressure <90 mmHg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290082
Locations
| France | |
| Emergency Department | |
| Creteil, Paris, France | |
| Emergency Department | |
| Ghps, Paris, France | |
| Emergency Department | |
| Agen, France, 47923 | |
| Emergecy department | |
| Argenteuil, France, 95100 | |
| Emergency Department | |
| Bayeux, France, 74401 | |
| Emergency Department | |
| Bondy, France, 93143 | |
| Emergency Department | |
| Carcassonne, France, 11890 | |
| Emergency Department | |
| Clermont-ferrand, France, 63003 | |
| Emergency Department | |
| Dijon, France, 11890 | |
| Emergency Department | |
| Elbeuf, France, 76503 | |
| Emergency Department | |
| Grenoble, France, 38043 | |
| Emergency Department | |
| Kremlin Bicetre, France, 94275 | |
| Emergency Department | |
| Le Havre, France | |
| Emergency Department | |
| Le Mans, France, 72037 | |
| Emergency Department | |
| Lisieux, France, 97223 | |
| Emergency Department | |
| Montauban, France, 82013 | |
| Emergency Department | |
| Nantes, France, 44093 | |
| Emergency Department | |
| Pontoise, France, 95301 | |
| Emergency Department | |
| Raincy-Montfermeil, France, 93370 | |
| Emergency Department | |
| Roanne, France, 43328 | |
| Emergency Department | |
| St Etienne, France, 42055 | |
Sponsors and Collaborators
University Hospital, Rouen
Investigators
| Principal Investigator: | Fabienne FM Moritz, MD | University Hospital, Rouen |
| Responsible Party: | CHU-Hopitaux de Rouen, Delegation de la recherche clinique |
| ClinicalTrials.gov Identifier: | NCT00290082 History of Changes |
| Other Study ID Numbers: |
2004/055/HP French state grant |
| First Posted: | February 10, 2006 Key Record Dates |
| Last Update Posted: | March 11, 2015 |
| Last Verified: | March 2015 |
Keywords provided by University Hospital, Rouen:
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sedation midazolam loxapine |
agitation emergency department toxicological analysis |
Additional relevant MeSH terms:
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Psychomotor Agitation Dyskinesias Neurologic Manifestations Nervous System Diseases Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Midazolam Loxapine Adjuvants, Anesthesia Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Dopamine Antagonists Dopamine Agents |