- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02512055
Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions
July 28, 2015 updated by: Oya Yalcin Cok, Baskent University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Pediatric patients undergoing repeat radiotherapy session under ketamine sedation
|
Repeated ketamine 2 mg/kg administration intravenously for sedation during each radiotherapy sessions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total ketamine consumption during each session
Time Frame: peroperative 3 hours
|
peroperative 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recovery time
Time Frame: peroperative 3 hours
|
peroperative 3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tobias JD. Tolerance, withdrawal, and physical dependency after long-term sedation and analgesia of children in the pediatric intensive care unit. Crit Care Med. 2000 Jun;28(6):2122-32. doi: 10.1097/00003246-200006000-00079.
- Hoffman GM, Nowakowski R, Troshynski TJ, Berens RJ, Weisman SJ. Risk reduction in pediatric procedural sedation by application of an American Academy of Pediatrics/American Society of Anesthesiologists process model. Pediatrics. 2002 Feb;109(2):236-43. doi: 10.1542/peds.109.2.236.
- Lois F, De Kock M. Something new about ketamine for pediatric anesthesia? Curr Opin Anaesthesiol. 2008 Jun;21(3):340-4. doi: 10.1097/ACO.0b013e3282f82bde.
- Macnab AJ, Levine M, Glick N, Susak L, Baker-Brown G. A research tool for measurement of recovery from sedation: the Vancouver Sedative Recovery Scale. J Pediatr Surg. 1991 Nov;26(11):1263-7. doi: 10.1016/0022-3468(91)90594-j.
- Trujillo KA, Akil H. Inhibition of opiate tolerance by non-competitive N-methyl-D-aspartate receptor antagonists. Brain Res. 1994 Jan 7;633(1-2):178-88. doi: 10.1016/0006-8993(94)91538-5.
- Trujillo KA. The neurobiology of opiate tolerance, dependence and sensitization: mechanisms of NMDA receptor-dependent synaptic plasticity. Neurotox Res. 2002 Jun;4(4):373-91. doi: 10.1080/10298420290023954.
- Trujillo KA, Zamora JJ, Warmoth KP. Increased response to ketamine following treatment at long intervals: implications for intermittent use. Biol Psychiatry. 2008 Jan 15;63(2):178-83. doi: 10.1016/j.biopsych.2007.02.014. Epub 2007 Jun 13.
- Zapantis A, Leung S. Tolerance and withdrawal issues with sedation. Crit Care Nurs Clin North Am. 2005 Sep;17(3):211-23. doi: 10.1016/j.ccell.2005.04.011.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
July 24, 2015
First Submitted That Met QC Criteria
July 28, 2015
First Posted (Estimate)
July 30, 2015
Study Record Updates
Last Update Posted (Estimate)
July 30, 2015
Last Update Submitted That Met QC Criteria
July 28, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Adjuvants, Anesthesia
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Mydriatics
- Ketamine
- Atropine
Other Study ID Numbers
- KA09/247
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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