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Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions

Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02512055
Enrollment
33
Registered
2015-07-30
Start date
2012-05-31
Completion date
2014-05-31
Last updated
2015-07-30

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

Conditions

Conscious Sedation Failure During Procedure

Brief summary

Ketamine provides a safety zone for sedated but spontaneously ventilated children especially in remote conditions such as radiotherapy units where sedation is an essential practice for children to keep calm and motionless In this study, investigators planned to analyse ketamine doses needed and the recovery times in pediatric oncology patients undergoing repeated radiotherapy sessions.

Detailed description

Ketamine provides a safety zone for sedated but spontaneously ventilated children especially in remote conditions such as radiotherapy units where sedation is an essential practice for children to keep calm and motionless.However, there had been a disagreement about the ketamine doses needed for a continuous and steady level of sedation during repeated radiotherapy sessions in children. In this study, investigators planned to analyse ketamine doses needed and the recovery times in pediatric oncology patients undergoing repeated radiotherapy sessions.After approval from the Baskent University, School of Medicine, Ethics and Research Committee (KA09/247) and informed consents of the patients' guardians, 33 pediatric patients undergoing radiotherapy due to oncologic disorders were enrolled to receive ketamine 2 mg/kg and atropine 10 μg/kg.Patients' demographic data such as age, gender, weight, ASA physical status and duration and total number of radiotherapy sessions were noted. Total ketamine consumption to maintain the targeted sedation level during each session, additional dose administration and the recovery time were recorded. The adverse events such as apnea, laryngospasm, bronchospasm, desaturation, respiratory depression, bradycardia, sedation levels deeper or superficial than intended to, excessive salivation, allergy, nausea and vomiting and need for emergency medication were also noted after each session. The study drugs were prepared, labelled and administered by an anesthetist according to the study protocol and data were recorded by an anesthetist blind to the amount of the study drug used.

Interventions

DRUGKetamine

Repeated ketamine 2 mg/kg administration intravenously for sedation during each radiotherapy sessions

Sponsors

Baskent University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* pediatric patients undergoing radiotherapy due to oncologic disorders

Exclusion criteria

* Patients younger than 1 year and older than 14 year, * patients with cardiac, renal or liver function abnormalities, who were already under sedative drug treatment or allergic to the drugs to be used or the patients for whom the study drugs

Design outcomes

Primary

MeasureTime frame
Total ketamine consumption during each sessionperoperative 3 hours

Secondary

MeasureTime frame
Recovery timeperoperative 3 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026