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Comparison of the effects and side effects of midazolam, haloperidol and the combination of them in agitated patients

Comparison between the efficay of tranquillisation and side effects of midazolam, haloperidol and the combination of these two drugs on agitated patients in emergency rooms

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201301199162N8
Enrollment
126
Registered
2016-03-30
Start date
2016-03-15
Completion date
Unknown
Last updated
2018-02-22

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

In this study drugs which are going to be prepared by the method of Block Randomization would be injected to patients with agitated behavior scale score of more than 28. Midazolam(5 miligram=1cc), hal

Sponsors

Tehran University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Exclusion criteria:Unstable vital signs( systolic blood pressure less than 90mmHg ,pulse rate less than 60 or more than 120/min and level of consciousness lower than agitation);past medical history of seizure;patients with unknown drug poisoning;Severe agitated patients who can not wait for the effect of intramuscular form of drugs;Allergy to midazolam and haloperidol; Closed angle glaucoma; Parkinson disease;Pregnancy and lactation; Myasthenia gravis;Thyrotoxicosis; Bone marrow suppression; Disagreement of patient's relatives on participation in the survey;Patients with coagulotion disorders such as hemophilia whom intramuscular injection is contraindicated; Reversible causes of agitation such as hypoglycemia (blood sugar less than 50),pain due to MI;Prolonged QT in patients ECG (QT >0.44) Inclusion criteria: 18 to 80 years old gitated patients with agitated behavior scale score of more than 28 .

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Tranquilization(control of agitation). Timepoint: one hour after drug injection. Method of measurement: by physician with agitated behaviour scale.

Secondary

MeasureTime frame
Side effects include:seizure ,extrapyramidal reactions:dystonia,akathisia,tardive dyskinesia,dizziness,neuroleptic malignant syndrom,nausea and vomiting,apnea or respiratory depression,pain in site of injection,cardiorespiratory arest. Timepoint: 30,60,120 min after drug injection. Method of measurement: physician 's examination and also checking vital signs.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtousa Akhgar

Tehran University Of Medical Sciences

At.akhgar@gmail.com+98 21 6640 4377

Outcome results

None listed

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