Anxiety. Neurotic, stress-related and somatoform disorders
Conditions
Interventions
Intervention 1: Midazolam group: Midazolam syrup (Producted by Midazolam ampule and juice) / Two milligram (mg) in 1 milliliter (ml) / Midazolam Chloridric Acid / With single dose of 0.5 mg per kilog
Treatment - Drugs
Midazolam group: Midazolam syrup (Producted by Midazolam ampule and juice) / Two milligram (mg) in 1 milliliter (ml) / Midazolam Chloridric Acid / With single dose of 0.5 mg per kilogram (kg) up to a
Promethazine group: Promethazine syrup / Promethazine Chloridric Acid / With single dose of 0.5 mg per kg up to a maximum of 20 mg / Five mg in 5 ml / Oral / Once and two hours before surgery / Tehra
Control group: Oral / Injection water / With single dose of 2-5 ml / Once and 2 hours before surgery / Dana Company / Brand name: Injection water
Sponsors
Lorestan University of Medical Sciences, Vice chancellor for research
Eligibility
Sex/Gender
All
Age
3 Years to 8 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria:Children with 3-8 years old / With American Society of Anaesthesiologists (ASA) grade 1 and 2 / under general anaesthesia / elective surgery / lack of chronic disease, prematurity, growth retardation, brain disorders, vision and acoustic disorders / with a written consent form from parents. Exclusion criteria: History of allergy to used drugs in this study / Children with emergency surgery
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative anxiety. Timepoint: Before intervention, One hours and 30 minutes after intervention ( Separation's time of child from parent) , Two hours after intervention (Before induction of anaesthesia). Method of measurement: According to Yale Preoperative Anxiety Scoring (YPAS) by questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Age. Timepoint: Before intervention. Method of measurement: According to number of year by questionnaire.;Sex. Timepoint: Before intervention. Method of measurement: According to phenotype by questionnaire.;Blood pressure (BP). Timepoint: Before intervention, Two hours after intervention. Method of measurement: According to millimeter of Mercury by barometer.;Pulse rate (PR). Timepoint: Before intervention, Two hours after intervention. Method of measurement: According to number of heartbeat in minute by physical exam.;Respiratory rate (RR). Timepoint: Before intervention, Two hours after intervention. Method of measurement: According to number of breathing in minute by physical exam.;Nausea and vomiting. Timepoint: Before intervention, After surgery. Method of measurement: According to yes or no by questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Sedighe Nadri
Lorestan University of Medical Sciences
Outcome results
None listed