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comparing the effect of short acting benzodiazpine with long acting in chemical restraint of patients with acute agitation and violence distubance behavior, referred to arak valiasre hospital

comparing the effect of short acting benzodiazpine with long acting in chemical restraint of patients with acute agitation and violence distubance behavior, referred to arak valiasre hospital

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260512069370N1
Enrollment
92
Registered
2026-05-14
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

comparing the effect of short acting benzodiazpine with long acting in chemical restraint of patients with acute agitation and violence distubance behavior, referred to arak valiasre hospital.

Interventions

Intervention 1: Intervention group: Intervention group: Group 1: Midazolam (short-acting benzodiazepine) Drug: Midazolam (5 mg ampoule) Dosage and administration: Slow intravenous injection, maximum d

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1- Patients with severe agitation and harm to themselves or others with the approval of an emergency medicine specialist2- Patients with severe agitation and harm that is not controlled by physical restraint3- Patients with severe agitation and harm aged 15 to 654- Patients with severe agitation and harm of both sexes5- No prior history of epilepsy or concomitant use of benzodiazepines or antipsychotics6- No breastfeeding or pregnancy7- Known history of allergy to benzodiazepines8- Head trauma

Exclusion criteria

Exclusion criteria: 1- Side effects of benzodiazepines 2- Shock 3- Failure to control symptoms and need for another method or medication such as antipsychotics

Design outcomes

Primary

MeasureTime frame
Onset of effect of midazolam and diazepam: Time in minutes until the patient calms down and stops risky behaviors. Required amount of midazolam and diazepam: Dosage of the drug that each patient receives and the number of times the drug is repeated. Duration of sedation of midazolam and diazepam: The time the patient is calm in minutes. Improvement after sedation of midazolam and diazepam: The patient's need for another action or re-administration of the same drug or a drug from a different class. Hemodynamic changes of midazolam and diazepam: Changes in blood pressure, pulse, respiratory rate, body temperature, and SPO2, which are recorded initially and the patient is monitored for cardiopulmonary function and re-recorded every 15 minutes. Short-term side effects of midazolam and diazepam: The occurrence of complications such as shock, symptoms of drug allergy, severe hemodynamic changes, pain at the injection site, and forgetfulness of events. Timepoint: Time in minutes until the patient calms down and stops risky behaviors. Method of measurement: It is calculated from the moment the drug is completely injected until the patient reaches a score of 0 to -2 on the RASS (Richmond Agitation-Sedation Scale) and recorded every 2 minutes.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Simin Najafgholian

Arak University of Medical Sciences

D_snaj@hotmail.com+98 86 6565 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026