CSF pharmacokinetics of a bolus dose intravenous diclofenac (Dyloject)

• Research type

  Research Study

• Full title

  The cerebrospinal fluid (CSF) pharmacokinetics of a single pre-operative intravenvous bolus dose of diclofenac (Dyloject) in comparison to diclofenac infusion (Voltarol)

• IRAS ID

  2804

• Sponsor organisation

  Barts and The London NHS Trust

• Eudract number

  2008-007309-35

• ISRCTN Number

  N/A

• Research summary

  <table cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="padding-right: 9pt; padding-left: 9pt; padding-bottom: 0cm; padding-top: 0cm"> The effectiveness of painkillers depends partly on the time they take to reach adequate concentration in the brain and spinal cord. This study is designed to evaluate a pain killing drug called diclofenac by comparing a recently licensed rapid injection version of the painkiller with the existing one which is given slowly over 30 minutes. It is hoped that this new drug format (Dyloject) will allow a more rapid build up in the body and so enable the drug to penetrate quicker into the brain and spinal cord, where pain is commonly controlled. This may stop pain earlier compared to previous slow intravenous infusions of diclofenac (Voltarol). By measuring the drug levels within the both the blood and cerebrospinafludflud surrounding the brain and spinal cord) directly we hope to find out how well and over what time course this new diclofenac formulation penetrates into the brain and spinal cord and therefore whether it will provide a better basis for controlling patients acute pain. This study is a comparative investigation where participants will receive diclofenac intravenously either as a single bolus dose (Dyloject) or as an infusion (Voltarol). All patients will be routinely undergoing spinal anaesthesia for planned surgery. This means an anaesthetic is planned whereby an injection through the lower part of the back into the cerebrospianflud numbs the lower half of the body allowing surgery to be completed, usually while the patient is awake, without feeling pain or discomfort. During this process a small amount of thflud will be removed and a blood sample taken. The blood sample will be taken from cannulas (tubes placed in veins) that are normally used for any form of anaesthesia. The study is funded by Javelin Pharmaceuticals, Inc and will be conducted at Barts and The London NHS Trust. </td> </tr> </tbody></table>

• REC name

  London - South East Research Ethics Committee

• REC reference

  09/H1102/8

• Date of REC Opinion

  19 Jan 2009

• REC opinion

  Favourable Opinion