A COMPARATIVE STUDY OF INTRANASAL DEXMEDETOMIDINE AND INTRANASAL MIDAZOLAM FOR PREMEDICATION IN CHILDREN POSTED FOR TONSILLECTOMY

Completed

• Conditions: Children of age 6 to 12 yrs of ASA physical status 1 undergoing elective tonsillectoy.

• Registration Number: CTRI/2021/07/034831
• Lead Sponsor: Sri Manakula Vinayagar Medical College and Hospital

Brief Summary

A randomized double blind contro; clinical study was done in 100 children with age group 6 to 12 belonging to asa physical status 1,scheduled for tonsillectomy under general anaesthesia. The present study was to compare satisfactory sedation,co-operation for mask induction and alleviation of anxiety. The study group,group D (Dexmedetomidine, n=50) received 1mcg/kg of intranasal dexmedetomidine and group M (Midazolam, n=50) received 0.2mg/kg of intranasal midazolam. The two group were similar with regards to age,gender,duration of surgery and duration of anaesthesia,extubation time. Premedication in paediatric patients using intranasal dexmedetomidine is more effective than intranasal midazolam in providing sedation and satisfactory conditions during parental separation. In term of providing ambient conditions during mask induction, both the drugs midazolam and dexmedetomidine are equally effective. There is no clinically significant difference in the hemodynamic parameters between the two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-21
• Study Completion: 2014-12-03
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Undergoing Elective Tonsillectomy ASA physical status I.

Exclusion Criteria

• 1.Recent upper respiratory tract infection/lower respiratory tract infection 2.Known allergy or Hypersensitivity reaction to dexmedetomidine or midazolam.
• 3.Renal and Hepatic failure 4.Leukaemia 5.Cardiac arrthymias 6.Congenital diseases 7.DEvelopmental delay.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the effect of intranasal Dexmedetomidine 1mcg/kg and Intranasal Midazolam 0.2mg/kg administered one hour before induction to asses hemodynamics,sedation,co-operation for mask induction,anxiety level	Hemodynamic-0 min to 120 min and sedation,co-operation for mask induction,anxiety level asses 0 min to 70 min.

Secondary Outcome Measures

Name	Time	Method
Childs acceptance of intranasal drugs	Incidence of side effect

Trial Locations

Locations (1)

Sri Manakula Vinayagar Medical College and Hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

Sri Manakula Vinayagar Medical College and Hospital

🇮🇳Pondicherry, PONDICHERRY, India

Dr Girimurugan N

Principal investigator

9840469518

drgirimurugan@gmail.com