Effect of Promethazine and Midazolam on preoperative anxiety

Phase 2

• Conditions: Anxiety.; Neurotic, stress-related and somatoform disorders; F40, F41,

• Registration Number: IRCT2012073010447N1
• Lead Sponsor: orestan University of Medical Sciences, Vice chancellor for research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 123

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.