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.

Intervention / Treatment

  • Drug: Ketamine

Condition or Disease

  • Conscious Sedation Failure During Procedure

Phase

Study Design

Study type: Interventional
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
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
Minimum Age: 1
Maximum Age: 14

More Details

NCT Number: NCT02512055
Other IDs: KA09/247
Study URL: https://ClinicalTrials.gov/show/NCT02512055
Last updated: Jun 17, 2022