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Sedation of children prior to the surgery using nebulization of two doses of a same drug called dexmedetomidine to reduce parental separation anxiety.

THE EFFECT OF TWO DOSES OF NEBULISED DEXMEDETOMIDINE FOR PREMEDICATION OF PEDIATRIC PATIENTS-A RANDOMISED STUDY

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040637
Enrollment
78
Registered
2022-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Health Condition 1: N51- Disorders of male genital organs in diseases classified elsewhere Health Condition 2: H260- Infantile and juvenile cataract Health Condition 3: C692- Malignant neoplasm of retina Health Condition 4: K358- Other and unspecified acute appendicitis Health Condition 5: Q321- Other congenital malformations oftrachea Health Condition 6: K638- Other specified diseases of intestine Health Condition 7: N288- Other specified disorders of kidney and ureter Health Condition 8: R098-

Interventions

Intervention1: Group B - 39 patients, 3 microgram/kg dexmedetomidine mixed in normal saline to make a total volume of 3 ml.: Group B will receive nebulisation with dexmedetomidine at a dose 3mcg/kg di

Sponsors

Gauhati Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age group 1-8 years. 2.American Society of Anaesthesiologists physical status 1 or 2 3.Availability of informed consent. 4.Any gender

Exclusion criteria

Exclusion criteria: 1. Parents refusal. 2.Patients with history of cardiac disease,asthma,seizure disorders. 3.patients with mental retardation,developmental delay or any congenital anomalies. 4.Patients with known allergy to dexmedetomidine.

Design outcomes

Primary

MeasureTime frame
Parental seperation anxiety score and mask acceptance scoreTimepoint: 30 mins after beginning of nebulisation.

Secondary

MeasureTime frame
To access emergence agitation post operatively.Timepoint: Immediately after emergence;To access hemodynamic variables intraoperatively. Timepoint: 10 minutes interval introperatively;To access post operative sedation.Timepoint: 1 hour and 2 hours post operatively.

Countries

India

Contacts

Public ContactDr Sanchita Sarma Borkataki

Gauhati Medical College

sbsarma1@gmail.com9435046228

Outcome results

None listed

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