Comparison of intranasal Dexmedetomidine vs intranasal Ketamine as premedication for level of sedation in children undergoing radiation therapy

Phase 4

• Conditions: Health Condition 1: null- children admitted for radiation therapy

• Registration Number: CTRI/2018/02/011781
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Clinical indication for a radiotherapy proceedure.

2. Children with (ASA) physical status (PS) I, II and III.

3.Parents who agreed to participate in the study and have signed written informed consent

Exclusion Criteria

Exclusion Criteria:

1.Unwilling parents

2.Active, uncontrolled gastroesophageal reflux, vomiting

3.Active, current respiratory issues those are different from the baseline status (pneumonia, exacerbation of asthma, bronchiolitis, respiratory synctitial virus)

4.Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction, current use of digoxin, beta blockers or calcium channel blockers)

5.Craniofacial anomaly, which could make it difficult to establish a mask airway for positive pressure ventilation if needed.

6.Space occupying lesions with increased intracranial tension with or without convulsions.

7.Multiple sites of radiotherapy requiring position change intra procedurally.

8.If volume for premedication exceeds more than 1 ml. (unacceptable for patient with intranasal medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of intranasal dexmedetomidine in comparison to intranasal ketamine as premedication for level of sedation in children at the time of shifting to radiotherapy suiteTimepoint: 45 minutes after administration of intranasal drug

Secondary Outcome Measures

Name	Time	Method
To asses Propofol dosage requirements between three groups for sedation during the procedure.Timepoint: during radiotherapy proceedure