Skip to main content
OpenTrials
Completed

NCT Number: NCT02512055

Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketamine

Drug

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

Other names: Atropine

Primary outcomes

  1. Total ketamine consumption during each session

    Time frame: peroperative 3 hours

Secondary outcomes

  1. Recovery time

    Time frame: peroperative 3 hours

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2015
Registry last updated
Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.