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Sedation of children prior to the surgery using medication to reduce parenteral separation anxiety

Comparison of Nebulized Dexmedetomidine versus Combination of Ketamine and Midazolam for Premedication in Preschool Children Undergoing Elective Surgery- A Prospective Randomized Double Blinded Study

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018344
Enrollment
60
Registered
2019-03-29
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: K402- Bilateral inguinal hernia, withoutobstruction or gangrene

Interventions

Intervention1: Nebulization of dexmedetomidine or ketamine midazolam mixture: Giving nebulization of dexmedetomidine versus ketamine midazolam mixture as a premedication for preschool choldren underg

Sponsors

S Nijalingappa Medical college and HSK Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II Age between 3-7 years undergoing elective surgery

Exclusion criteria

Exclusion criteria: Patients with known allergy to study drug Patients with significant organ dysfunction Patients with cardiac dysrhythmia Patients with congenital heart diseases,use of psychotropic medication Mental retardation

Design outcomes

Primary

MeasureTime frame
To assess the degree of sedation between group A (nebulised dexmedetomidine)and group B( combined midazolam+ketamine)Timepoint: assessed before (0 min,baseline) and at 5,10,20 and 30 min at the end of study drug administration

Secondary

MeasureTime frame
1.To assess parental separation anxiety score 2.To assess medication and mask acceptance inside O.T 3.To assess emergence agitation post operatively 4.To assess pain intensity post operatively using FLACC scaleTimepoint: before (0 min,baseline) and at 5,10,20 and 30 min at the end of study drug administration

Countries

India

Contacts

Public ContactArchana Endigeri

S N Medical College & HSK Hospital

archanaendigeri86@gmail.com7406568382

Outcome results

None listed

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