Title: A randomised three-way cross-over study comparing the pharmacokinetics of intranasal droperidol to intramuscular and intravenous droperidol in healthy volunteers
Research Study: Approved by the Monash Health HREC.
Prinipal Investigators: Professor Andis Graudins, Dr Isabelle Cooper
The aim of this study is to study whether a medication called Droperidol, can be absorbed effectively using an intranasal spray. Droperidol, administered intravenously or by injection, Droperidol is approved in Australia as an antipsychotic, to treat acute behavioural disturbance (ABD) and nausea and vomiting.
This is a randomized research study comparing how droperidol is absorbed by your body, after a single dose of droperidol is given either intravenously, by intramuscular injection, or using an intranasal spray. You will be given droperidol on three separate occasions, each time by one of the three different administration methods.
You will be asked to visit Dandenong Hospital Emergency Department for a full day on three occasions, at least one week apart. On each study day, you will have to start the study after fasting for at least 6 hours and abstaining from caffeinated beverages for at least 24 hours. Your heart function, respiration rate and oxygen saturation will be monitored on study days. To undertake the study treatments and blood sampling required for this study, you will have to have a catheter inserted into a vein on either your left and right arm. It will be used to take 10 small blood samples over 12 hours (total volume 100ml) to measure concentrations of droperidol.
You will not be paid for participating in this study but will be provided with meals and beverages on study days.
If you are interested in participating in this study, please contact a study researcher (Professor Andis Graudins or Dr Isabelle Cooper) on 9554-9340 or email andis.graudins@monashhealth.org.
INCLUSION CRITERIA
• Healthy adult males aged between 18 and 55 years
• Body weight > 50kg and < 100 kg with BMI < 28
EXCLUSION CRITERIA
• Allergy to droperidol
• Previous history of any dystonic reaction to medications
• Previous nasal surgery or nasal trauma that may interfere with administration of absorption of intranasal medication
• Current upper respiratory tract infection
• Use of any prescription or non-prescription drugs that may affect droperidol metabolism.
• Any known heart, gut, lung, kidney or liver disease
• Any antipsychotic medication use.
Prinipal Investigators: Professor Andis Graudins, Dr Isabelle Cooper
The aim of this study is to study whether a medication called Droperidol, can be absorbed effectively using an intranasal spray. Droperidol, administered intravenously or by injection, Droperidol is approved in Australia as an antipsychotic, to treat acute behavioural disturbance (ABD) and nausea and vomiting.
This is a randomized research study comparing how droperidol is absorbed by your body, after a single dose of droperidol is given either intravenously, by intramuscular injection, or using an intranasal spray. You will be given droperidol on three separate occasions, each time by one of the three different administration methods.
You will be asked to visit Dandenong Hospital Emergency Department for a full day on three occasions, at least one week apart. On each study day, you will have to start the study after fasting for at least 6 hours and abstaining from caffeinated beverages for at least 24 hours. Your heart function, respiration rate and oxygen saturation will be monitored on study days. To undertake the study treatments and blood sampling required for this study, you will have to have a catheter inserted into a vein on either your left and right arm. It will be used to take 10 small blood samples over 12 hours (total volume 100ml) to measure concentrations of droperidol.
You will not be paid for participating in this study but will be provided with meals and beverages on study days.
If you are interested in participating in this study, please contact a study researcher (Professor Andis Graudins or Dr Isabelle Cooper) on 9554-9340 or email andis.graudins@monashhealth.org.
INCLUSION CRITERIA
• Healthy adult males aged between 18 and 55 years
• Body weight > 50kg and < 100 kg with BMI < 28
EXCLUSION CRITERIA
• Allergy to droperidol
• Previous history of any dystonic reaction to medications
• Previous nasal surgery or nasal trauma that may interfere with administration of absorption of intranasal medication
• Current upper respiratory tract infection
• Use of any prescription or non-prescription drugs that may affect droperidol metabolism.
• Any known heart, gut, lung, kidney or liver disease
• Any antipsychotic medication use.
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