Visceral Pain From the Upper Urinary Tract - a Trial on the Effect of Morphine and Oxycodone in Patients Undergoing PCNL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00784472|
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : July 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Kidney Stones||Drug: oxycodone Drug: morphine||Phase 3|
Primary outcome: the amount of opioid (morphine or oxynorm) used the first 4 hours postoperatively.
Secondary outcome: side effect to the opioids, pain score, pain threshold to electrical stimulation and pressure before and after operation, pharmacogenetics, size of referred pain area.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Visceral Pain Originating From the Upper Urinary Tract - a Randomized Controlled Trial on the Effect of Morphine and Oxycodone in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|Active Comparator: oxycodone||
intravenous according to patients weight, pn.
Other Name: oxynorm N02A A05
|Active Comparator: morphine||
intravenous administration according to patients weight, pn.
Other Name: morphine SAD N02 AA 01
- Amount of analgetics used [ Time Frame: four hours postoperatively ]
- Side effects [ Time Frame: four hours postoperatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784472
|Hospital Little Belt, Fredericia|
|Fredericia, Denmark, 7000|
|Study Chair:||Palle Osther, Professor||Hospital Little Belt, Fredericia|
|Principal Investigator:||katja Venborg Pedersen, MD||Hospital Little Belt, Fredericia|