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Comparison of sedation effect of midazolam and muscle haloperidol in treatment of agitation of patients referring to emergency

Comparison of sedation effect of midazolam and muscle haloperidol in treatment of agitation of patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200720048146N1
Enrollment
120
Registered
2020-10-04
Start date
2020-10-22
Completion date
Unknown
Last updated
2020-10-06

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

Conditions

Agitation. Restlessness and agitation

Interventions

Intervention 1: Intervention group: Haloperidol 5mg is prepared by block randomization method. It is coded by the researcher, so that the doctor and the patient do not know the type of injectable drug

Sponsors

Zahedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: Includes age 15 to 60 years Class ? ASA ? Score above 28 on the agitation measurement scale

Exclusion criteria

Exclusion criteria: Patient dissatisfaction (or legal partner) Unstable vital signs (blood pressure less than 90 mm Hg, heart rate below 60 and above 120 beats per minute, oxygen saturation level below 90%, level of consciousness less than agitation) History of heart disease and liver and kidney failure Pregnancy and lactation The patient is very restless and has the potential to harm himself and others and can not wait for a response to intramuscular injection of the drug. Poisoning with an unknown drug A history of active seizures requires medication Myasthenia Gravis Bone marrow suppression Patients with coagulation disorders such as hemophilia in whom intramuscular injection is contraindicated Thyrotoxicosis Hypersensitivity to midazolam or haloperidol

Design outcomes

Primary

MeasureTime frame
Agitation. Timepoint: The patient is monitored for two hours after the injection. After 30, 60 and 15 minutes, they are measured for drug response (agitation control) and at the end of two hours for side effects. Method of measurement: Drug response rate is defined according to the agitation measurement scale (score less than 28).;Midazolam and haloperidol. Timepoint: At the beginning of the intervention. Method of measurement: Medications containing midazolam 5mg, or haloperidol 5mg, are prepared by block randomization. They are coded by the person in charge of the research, so that the doctor and the patient do not know the type of injectable drug. After obtaining the consent of the patient and having the desired criteria, the drugs are injected intramuscularly into the patient's left deltoid muscle with a 2 cc syringe.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactmohammad hossein Ajdari

Zahedan University of Medical Sciences

mohamadhosenajdary1347zabol@gmail.com+98 54 3251 9517

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026