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

A Comparative Study Of Intranasal Dexmedetomidine And Intranasal Midazolam For Premedication In Children Posted For Tonsillectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/07/034831
Enrollment
100
Registered
2021-07-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Children of age 6 to 12 yrs of ASA physical status 1 undergoing elective tonsillectoy.

Interventions

Intervention1: Premedication with intranasal Dexmedetomidine (selective alpha-2 agonist): Intranasal Dexmedetomidine at dose of 1mcg/kg administered in preoperative holding area one hour before induct

Sponsors

Sri Manakula Vinayagar Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Undergoing Elective Tonsillectomy ASA physical status I

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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 levelTimepoint: Hemodynamic-0 min to 120 min and sedation,co-operation for mask induction,anxiety level asses 0 min to 70 min.

Secondary

MeasureTime frame
Childs acceptance of intranasal drugs Incidence of side effectTimepoint: when premedication is administered throughout the procedure and upto 1 hours after the end of procedure

Countries

India

Contacts

Public ContactDr Girimurugan N

Sri Manakula Vinayagar Medical College and Hospital

drbalasubbu77@gmail.com9940764982

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026