Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions

NCT ID: NCT02512055

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-05-31

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.

Conditions

Conscious Sedation Failure During Procedure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1

Pediatric patients undergoing repeat radiotherapy session under ketamine sedation

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Interventions

Ketamine

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

Intervention Type: DRUG

Other Intervention Names

Atropine

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baskent University

OTHER

Sponsor Role: lead

Responsible Party

Oya Yalcin Cok

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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Other Identifiers

KA09/247

Identifier Type: -

Identifier Source: org_study_id