A study to evaluate whether increased codeine levels are seen when both codeine and ketamine are given in small doses to well volunteers.
Mechanistic basis for the use of ketamine as an adjuvant to opioid analgesia – a pharmacokinetic drug-drug interaction study to define any clinically relevant drug to drug interaction between codeine and ketamine in healthy volunteers.
Flinders University- Department of Clinical Pharmacology
10 participants
Dec 21, 2009
Interventional
Conditions
Summary
Pain from damaged nerves is a common problem particularly in the aged and those with medical problems including diabetes, vascular disease and cancer.A medication called ketamine which is used for anaesthetics is, at much lower doses, also used to help try and control severe chronic nerve pain. In an experiment that has been carried out at Flinders University in the laboratory, it appears that ketamine may increase the effective blood levels of opioid pain killers such as codeine or morphine that are often given in conjunction with ketamine. This study will evaluate whether increased codeine levels are seen when both codeine and ketamine are administered in small doses to well volunteers.Ketamine is already being evaluated in a clinical study by a team led by Flinders University at eight sites across Australia for severe nerve-based pain. This study will be a definitive study on the place of ketamine in the control of chronic, complex pain and should be finished in mid-2010.This study will have huge importance if ketamine is shown to be of clinical benefit. To date, it may well be that the perceived clinical benefit is only because of its effect on increasing the blood levels of strong pain killers.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Study exposure is for 4 days and commences with a comprehensive medical assessment to identify that the participants meet the eligibility criteria.Participants will take in total 9 doses of 30mg of codeine orally every 8 hours. The first 5 doses will be taken at home, ie days 1 and 2 of the study. On day 3 the participants will continue to take the codeine 30mg every 8 hours orally but will be monitored in hospital from 08.00 to 16.00. 11 samples of blood will be taken at predetermined times throughout the day and at the same time vital signs, pulse, respirations and blood pressure, will be measured by a registered nurse. On day 4 the participant will again be monitored in hospital from 08.00 hours to 16.00 hours. The final dose of codeine 30mg orally will be given at 08.00 hours and at the same time ketamine 0.5mg per kg of body weight up to a maximum of 40mg will be given intravenously over 5 minutes. Again 11 blood samples will be taken at predetermined times throughout the day, and vital signs , pulse, respirations and blood pressure will be measured at the same time. An intravenous cannual, a small plastic tube, will be inserted into a vein in the arm on both days 3 and 4 which will be used to collect the 11 blood samples on each day, thus eliminating the need to insert a needle into the vein each time a blood sample is required. On both days 3 and 4, whilst in hospital, all urine passed by the participants will be collected.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12610000283077