FindTrial
Sign In

Dexmedetomidine versus ketamine by administration as nasal spray for sedation in children undergoing spine surgery

Comparison of the efficacy of Intranasal Atomised Dexmedetomidine versus Intranasal Atomised ketamine as a premedicant for anxiolysis and sedation in paediatric population aged 1-10 years undergoing spinal dysraphism surgery - a randomised double blinded controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042249
Enrollment
64
Registered
2022-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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: Patients will receive single dose of intranasal atomised dexmedetomidine 2.5μg/kg 30minutes before induction.: Calculated single dose of 2.5ug/kg dexmedetomidine will be diluted to 2m

Sponsors

Ankur Luthra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 64 ASA I and II children aged between 1-10years scheduled for spinal dysraphism surgery will be enrolled in this study.

Exclusion criteria

Exclusion criteria: Refusal of consent Known allergy to dexmedetomidine or ketamine ASA III or IV Children with cardiac anomalies Children with seizures Children with upper respiratory tract infection Children with liver disease Children with mental retardation Difficult cannulation (three or more attempts)

Design outcomes

Primary

MeasureTime frame
To compare the effectiveness of sedation between intranasal atomised dexmedetomidine versus intranasal atomised ketamine in pediatric population aged 1-10yr undergoing spinal dysraphism surgery by using University of Michigan Sedation Scale (UMSS).Timepoint: At 30 minutes post drug administration via intranasal route.—

Secondary

MeasureTime frame
To compare the hemodynamic changes (HR, MAP, SpO2) intraoperativelyTimepoint: 35 min, 40 min, 45 min, 50 min, 55 min, 60 min, 65 min, 70 min, 75 min, 80 min, 85 min and 90 min after drug administration;To compare the response to parental separation assessed by Parental Separation Anxiety Score (PSAS)Timepoint: 30 min after drug administration;To compare the successful rate of venous canulation assessed by Groningen Distress Rating ScoreTimepoint: 30 min after drug administration;To compare the time for post operative discharge from PACU by Modified Aldrete ScoringTimepoint: At the end of PACU stay;To compare incidence of Emergence agitation assessed by using WATCHA ScaleTimepoint: At the end of surgery;To compare mask acceptance assessed by Mask Acceptance ScaleTimepoint: 30 min after drug administration—

Countries

India

Contacts

Public ContactDr Chethan Hebbar K

Postgraduate institute of medical Education and research, Chandigarh

zazzydude979@gmail.com9868057732

Outcome results

None listed

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