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Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions

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ClinicalTrials.gov Identifier: NCT02512055
Recruitment Status : Completed
First Posted : July 30, 2015
Last Update Posted : July 30, 2015
Sponsor:
Information provided by (Responsible Party):
Oya Yalcin Cok, Baskent University

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 Intervention/treatment Phase
Conscious Sedation Failure During Procedure Drug: Ketamine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions
Study Start Date : May 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Group 1
Pediatric patients undergoing repeat radiotherapy session under ketamine sedation
Drug: Ketamine
Repeated ketamine 2 mg/kg administration intravenously for sedation during each radiotherapy sessions
Other Name: Atropine




Primary Outcome Measures :
  1. Total ketamine consumption during each session [ Time Frame: peroperative 3 hours ]

Secondary Outcome Measures :
  1. Recovery time [ Time Frame: peroperative 3 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications:
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Responsible Party: Oya Yalcin Cok, Associate Professor, Baskent University
ClinicalTrials.gov Identifier: NCT02512055     History of Changes
Other Study ID Numbers: KA09/247
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action