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

Comparison of intranasal Dexmedetomidine vs intranasal Ketamine as premedication for level of sedation in children undergoing radiation therapy: A Prospective, Randomized, Double Blind study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/011781

Enrollment

300

Registered

2018-02-08

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: null- children admitted for radiation therapy

Interventions

Intervention1: Dexmedetomidine: Dexmedetomidine at a dosage of 2.5 micro grams/kg through intranasal route administered only once and observed for 6 hours after completion of procedure. Control Interv

Eligibility

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To asses Propofol dosage requirements between three groups for sedation during the procedure.Timepoint: during radiotherapy proceedure	—

Countries

India

Contacts

Public ContactPRANEETH SUVVARI

AIIMS, New Delhi

seemamishra2003@gmail.com9899061105

Outcome results

None listed

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