CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
ketamine hydrochloridedrug
Likely dose
ketamine hydrochloride 2 mg/kgfrom record
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Search/NCT00553839
NCT00553839N/ACompleted

Pharmacokinetics of Ketamine in Infants and Children

Stanford University·interventional·Posted Nov 6, 2007·Updated Feb 8, 2016

In Brief

A clinical study evaluating ketamine hydrochloride for The Pk of IV Ketamine in Children With Heart Disease. Completed, enrolled 21 participants across 2 sites.

Detailed Summary

Dosing of medications is based on the plasma level achieved with a given dose and how long the medicine remains in the body. This study is called pharmacokinetics-that is, what the body does to the medication. Ketamine is an intravenous medication used for anesthesia and sedation in children. However the pharmacokinetics of Ketamine has not been systematically studied. We propose to study the pharmacokinetics of ketamine in different age groups of children ranging from infants to teenagers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2007
Enrollment StartJul 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.7 years ago

Interventions

ketamine hydrochloridedrug

Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.