Comparison of two different drug given before the surgery in paediatric patients surgery to reduce pre operative anxiety

Comparative study between Intranasal Dexmedetomidine versus Intranasal Midazolam with Oral Promethazine as common premedication in paediatric patients posted for surgery: A Randomized prospective study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096622

Enrollment

Registered

2025-10-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

Health Condition 1: Q348- Other specified congenital malformations of respiratory system

Interventions

Intervention1: intranasal Dexmedetomidine or Midazolam with oral promethazine as common premedication in paediatric patients posted for surgery: In pediatric patient age between 2-7 years posted for a

oral promethazine given 120 minutes and intranasal drug given 30 minutes prior to induction according to fixed dose. Control Intervention1: oral promethazine as common premedication in paediatric pati

Eligibility

Inclusion criteria

Inclusion criteria: 1)Weight: 5-20 kg 2)ASA grading 1,2,3

Exclusion criteria

Exclusion criteria: 1)Parent refusal 2)Any comorbidities /congenital deformity. 3)Active Upper respiratory tract infection.

Design outcomes

Primary

Measure	Time frame
1)To compare degree of sedation between two group at time of patient will be shifted to operation room using Modified Observer’s Assessment of Alertness/Sedation. Timepoint: 1)Sedation level will be assessed using the Modified Observer’s Assessment of Alertness/Sedation Scale (MOAA/S) at every 0, 30,60, 90, 100, 110, 120 minutes.	—

Secondary

Measure	Time frame
1)To assess the ease of parental separation when patient will be separated from parents & shifted to operation room. 2)To assess mask acceptance during anaesthesia induction. 3)To monitor hemodynamic parameters including heart rate, blood pressure, oxygen saturation(SpO2) & Respiratory rate (RR); at o min will be recorded before giving oral promethazine for every 30 minutes up to intranasal drug given & every 10 minutes after intranasal drug administration up to induction of anaesthesia(Every 0, 30,60, 90, 100, 110, 120 minutes) 4)To record adverse effects; if any, associated with either of study groups. Timepoint: 1)At baseline(before intranasal drug),30 , 60, 90,100,110,120 minutes 2)Ease of parental separation will be scored at the time when patient will shift to operation room. 3)Mask acceptance during anaesthesia induction.	—

Measure

Time frame

1)To assess the ease of parental separation when patient will be separated from parents & shifted to operation room. 2)To assess mask acceptance during anaesthesia induction. 3)To monitor hemodynamic parameters including heart rate, blood pressure, oxygen saturation(SpO2) & Respiratory rate (RR); at o min will be recorded before giving oral promethazine for every 30 minutes up to intranasal drug given & every 10 minutes after intranasal drug administration up to induction of anaesthesia(Every 0, 30,60, 90, 100, 110, 120 minutes) 4)To record adverse effects; if any, associated with either of study groups. Timepoint: 1)At baseline(before intranasal drug),30 , 60, 90,100,110,120 minutes 2)Ease of parental separation will be scored at the time when patient will shift to operation room. 3)Mask acceptance during anaesthesia induction.

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Countries

India

Contacts

Public ContactDr Dhruvi Rinkeshkumar Patel

GMERS Medical college and hospital, Gotri

santosh19692001@gmail.com9979877486

Outcome results

None listed

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