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Comparing two drugs for making the child sleep during radiation treatment

Comparison of Two Sedation Techniques for External Beam Radiotherapy (EBRT) in Paediatric Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/039905
Enrollment
16
Registered
2022-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: D- Radiation Therapy

Interventions

Intervention1: Intravenous Ketamine: 1mg/kg Pre-procedure 0.5mg/kg boluses intraprocedural guided by Pediatric Sedation State Scale ,Face Legs Activity Cry Consolability Scale and bispectral index C

Sponsors

Rajiv Gandhi Cancer Institute and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Undergoing External Beam Radiotherapy under Sedation

Exclusion criteria

Exclusion criteria: No parental consent Retinoblastoma Radiation simulation Raised Intracranial Pressure Allergic to study drug

Design outcomes

Primary

MeasureTime frame
Pediatric Sedation State ScaleTimepoint: 0 minutes Baseline preprocedural 3 minutes after injection of intervention/comparator drug 6 minutes after injection of intervention/comparator drug 9 minutes after injection of intervention/comparator drug 0 minutes post-procedure 10 minutes post-procedure 30 minutes post-procedure

Secondary

MeasureTime frame
Heart RateTimepoint: 0 minutes Baseline preprocedural 3 minutes after injection of intervention/comparator drug 6 minutes after injection of intervention/comparator drug 9 minutes after injection of intervention/comparator drug 0 minutes post-procedure 10 minutes post-procedure 30 minutes post-procedure;Arterial oxygen SaturationTimepoint: 0 minutes Baseline preprocedural 3 minutes after injection of intervention/comparator drug 6 minutes after injection of intervention/comparator drug 9 minutes after injection of intervention/comparator drug 0 minutes post-procedure 10 minutes post-procedure 30 minutes post-procedure;Face Legs Activity Cry Consolibility ScaleTimepoint: 0 minutes Baseline preprocedural 3 minutes after injection of intervention/comparator drug 6 minutes after injection of intervention/comparator drug 9 minutes after injection of intervention/comparator drug 0 minutes post-procedure 10 minutes post-procedure 30 minutes post-procedure;Bispectral IndexTimepoint: 0 minutes Baseline preprocedural 3 minutes after injection of intervention/comparator drug 6 minutes after injection of intervention/comparator drug 9 minutes after injection of intervention/comparator drug 0 minutes post-procedure 10 minutes post-procedure 30 minutes post-procedure;Respiratory RateTimepoint: 0 minutes Baseline preprocedural 3 minutes after injection of intervention/comparator drug 6 minutes after injection of intervention/comparator drug 9 minutes after injection of intervention/comparator drug 0 minutes post-procedure 10 minutes post-procedure 30 minutes post-procedure;Richmond Agitation Sedation ScaleTimepoint: 0 minutes post-procedure 10 minutes post-procedure 30 minutes post-procedure

Countries

India

Contacts

Public ContactDr Swati Sahay

Rajiv Gandhi Cancer Institute and Research Centre

drshagun_2010@rediffmail.com09891769779

Outcome results

None listed

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