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AGItated Patients Management: intraNASAL Midazolam vs Intramuscular Loxapine

NCT05324852 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-05-28

No results posted yet for this study

Summary

This study is a non-inferiority phase III randomized trial evaluating the effect of intranasal midazolam versus intramuscular loxapine on the rapid tranquilization of agitated patient in emergency department. Intranasal midazolam is safe and may allow a management of extreme agitation state and prevent adverse effects.

Conditions

  • Emergence Delirium

Interventions

DRUG

Intranasal midazolam

Midazolam, 5 mg, injectable solution in 5mg/ml, intranasal administration, atomize into nose with Mucosal Atomizer Device (MAD) 5mg(1ml) up each nostril , one time

DRUG

Intramuscular loxapine

Loxapine, 100mg, injectable solution in 50mg/2ml intramuscular, intra muscular administration, one time

Sponsors & Collaborators

  • Lariboisière-Saint Louis clinical research unit

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Frédéric Adnet, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-09
Primary Completion
2023-04-09
Completion
2024-04-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05324852 on ClinicalTrials.gov