Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions

Conscious Sedation Failure During Procedure Clinical Trial

Official title:

Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512055
• Other study ID #: KA09/247
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2015
• Last updated: July 28, 2015
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2015
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Conscious Sedation Failure During Procedure

Intervention

Drug:
• Ketamine
Repeated ketamine 2 mg/kg administration intravenously for sedation during each radiotherapy sessions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

References & Publications (8)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2007 Jun 13. — View Citation

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. — View Citation

Zapantis A, Leung S. Tolerance and withdrawal issues with sedation. Crit Care Nurs Clin North Am. 2005 Sep;17(3):211-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total ketamine consumption during each session		peroperative 3 hours
Secondary	Recovery time		peroperative 3 hours