Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions
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.
Condition or Disease
- Conscious Sedation Failure During Procedure
Phase
Study Design
Study type: | Interventional |
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Status: | Completed |
Study results: | No Results Available |
Age: | 1 Year to 14 Years (Child) |
Enrollment: | 33 () |
Funded by: | Other |
Masking |
Clinical Trial Dates
Start date: | May 12, 2022 | |
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Primary Completion: | May 14, 2022 | |
Completion Date: | May 14, 2022 | |
Study First Posted: | Jul 30, 2015 | |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Jul 30, 2015 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
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.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 1 |
Maximum Age: | 14 |
More Details
NCT Number: | NCT02512055 |
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Other IDs: | KA09/247 |
Study URL: | https://ClinicalTrials.gov/show/NCT02512055 |
Last updated: Jun 17, 2022