Comparison of Dexmedetomidine and Midazolam as Intanasal Premedication in Childre

Phase 4

Completed

• Conditions: Health Condition 1: null- Children aged 2-10 years undergoing minor surgical procedures under general anaesthesiaHealth Condition 2: O- Medical and Surgical

• Registration Number: CTRI/2018/03/012807
• Lead Sponsor: Principle Investigator

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-12-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 104

Inclusion Criteria

Children aged 2-10 years undergoing minor surgical procedures under general anaesthesia

American Society of Anaestheiologists (ASA) Physical Status I & II grade of patients.

Exclusion Criteria

Parent refusal

Known allergy to the drugs under study.

Cardiac dysrhythmias and/or congenital heart disease

Psychotropic medication use

Mental retardation

Nasal disorders interfering with administration of medication as recurrent nasal bleeding or nasal masses.

Children who spat or refused intranasal administration of medication.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified observer�s Assessment of Alertness/Sedation scale (MOAA/S). <br/ ><br>Parental Separation Anxiety scale (PSAS). <br/ ><br>Mask Acceptance Score(MAS).Timepoint: Modified observer�s Assessment of Alertness/Sedation scale (MOAA/S). 30 minutes. <br/ ><br>Parental Separation Anxiety scale (PSAS). 30 minutes. <br/ ><br>Mask Acceptance Score(MAS). 30 minutes.

Secondary Outcome Measures

Name	Time	Method
pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubationTimepoint: pulse rate, BP, respiratory rate and oxygen saturation were recorded every 10 minute interval for 30 minutes from the time of extubation