Ketodex (Ketamine+dexmedetomidine) versus midazolam as nasal spray for sedation in children undergoing spine surgery

Comparison of the efficacy of Intranasal Atomised Ketodex versus Intranasal Atomised Midazolam as a Premedicant for anxiolysis and sedation in children aged 1 to 10 years undergoing spinal dysraphism surgery- A randomized double-blinded controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077125

Enrollment

Registered

2024-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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 be receiving Intranasal atomised ketodex (Ketamine 3mg/kg + Dexmed 1 mics/kg) 30 minutes before induction.: A calculated dose of ketamine 3 mg/kg and 1 mics/kg dexmedetomi

Eligibility

Inclusion criteria

Inclusion criteria: 70 ASA I and II children aged between 1-10 years who were 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

Measure	Time frame
Comparison of the effectiveness of sedation between intranasal atomised ketodex versus midazolam in children aged 1 to 10 years undergoing spinal dysraphism surgery by University of Michigan Sedation Scale (UMSS).Timepoint: 30 minutes after drug administration	—

Secondary

Measure	Time frame
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 the Groningen Distress Rating Score (GDRS)Timepoint: 30 min after drug administration;To compare mask acceptance assessed by the Mask Acceptance Scale (MAS)Timepoint: 30 min after drug administration;To compare the hemodynamic changes (HR, MAP, SpO2)Timepoint: 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 incidence of Emergence agitation assessed by using the WATCHA ScaleTimepoint: At the end of surgery and anaesthesia;To compare the time for post operative discharge from Post Anaesthesia Care Unit (PACU) by Modified Aldrete ScoringTimepoint: At the end of PACU stay	—

Measure

Time frame

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 the Groningen Distress Rating Score (GDRS)Timepoint: 30 min after drug administration;To compare mask acceptance assessed by the Mask Acceptance Scale (MAS)Timepoint: 30 min after drug administration;To compare the hemodynamic changes (HR, MAP, SpO2)Timepoint: 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 incidence of Emergence agitation assessed by using the WATCHA ScaleTimepoint: At the end of surgery and anaesthesia;To compare the time for post operative discharge from Post Anaesthesia Care Unit (PACU) by Modified Aldrete ScoringTimepoint: At the end of PACU stay

—

Countries

India

Contacts

Public ContactDr Shruti Bhatt

Postgraduate institute of Medical Education and Research, Chandigarh

zazzydude979@gmail.com9868057732

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026