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

Phase 3
Conditions
Restlessness and agitation
agitation.
Registration Number
IRCT201301199162N8
Lead Sponsor
Tehran University Of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
126
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)
18 to 80 years old gitated patients with agitated behavior scale score of more than 28 .

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Tranquilization(control of agitation). Timepoint: one hour after drug injection. Method of measurement: by physician with agitated behaviour scale.
Secondary Outcome Measures
NameTimeMethod
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.
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