Clinical Trial Results:
Dexmedetomidine infusion in pain management during low back surgery
Dexmedetomidine is an alpha-2-adrenergic agonist that is used mainly for sedation in the intensive care unit. Alpha-2-adrenoceptors agonists have several beneficial actions in a surgical patient. They decrease symphatetic tone, reduce anesthetic and opioid requirements and cause sedation and analgesia. Pain after low back surgery is intense and can become chronic. We need a new drug to manage pain during postoperative period and to prevent chronic pain.
DEXPAIN-study has been approved by Kuopio university hospitals ethics committee. Study is single centered, randomized and placebo-controlled study. A total of 60 patients scheduled for low back surgery will be enrolled in this study. Patients eligibility will be assessed by pre-determined inclusion-exclusion-criteria. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. Patients in the dexmedetomidine group receive dexmedetomidine loading dose 1ug/kg for 10 minutes and continuous infusion 1.4 ug/kg/h during surgery and post-anesthesia care unit. Total infusion time will be four hours. Anesthesia is standardized and post-operative pain is treated with patient controlled analgesia made of oxycodone. Questionnaires will be used to assess pain control.
Study is scheduled to start as soon as we obtain permission from Finnish Medicines Agency and receive sufficient funding.
Summary
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EudraCT number |
2015-002694-37 |
Trial protocol |
FI |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Dec 2024
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First version publication date |
06 Dec 2024
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Other versions |
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Summary report(s) |
Trialneverstarted |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.