Skip to content

A clinical trial to study the effects of combinations of three drugs dexmedetomidine,ketamine and midazolam for intranasal premedication in paediatric patients.

Comparision of intranasal dexmedetomidine-midazolam,dexmedetomidine-ketamine and midazolam-ketamine for premedication in paediatric patients: A double blinded randomized trial - Not applicable

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/11/016471
Enrollment
150
Registered
2018-11-30
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: O- Medical and Surgical

Interventions

Intervention1: 1. Group A(DM) : Patients pre-medicated with 1µg/kg dexmedetomidine and 0.15mg/kg midazolam intranasally . 2. Group B(DK) : Patients pre-medicated with 1µg/kg dexmedetomidine and 2mg

Sponsors

Aiims jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Paediatric patients of age 2-4 years belonging to ASA 1 posted for elective surgeries under general anaesthesia.

Exclusion criteria

Exclusion criteria: 1.Parent refusal 2.Recent history and active bleeding 3.Patient with nasal mass 4.Patient with active URI 5.Patient with history of psychiatric illness 6.Patient with cardiac arrythmia and congential heart disease 7.Patient with raised ICT and raised IOP 8.Patient with history of allergy to drugs been used 9.Children who fail to achieve parental separation even after 30 minutes of premedication

Design outcomes

Primary

MeasureTime frame
To assess the anxiety level at separation from parentsTimepoint: At 30 minutes of intranasal premedication in paediatric patients.

Secondary

MeasureTime frame
To assess the level of sedation, ease of iv cannulation ,mask acceptanceTimepoint: At 30 minutes of intranasal premedication in paediatric patients.

Countries

India

Contacts

Public ContactDr Vaishnavi B D

All India Institute Of Medical Sciences, Jodhpur

drshilpagoyal@yahoo.com8003996880

Outcome results

None listed

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