Visceral Pain From the Upper Urinary Tract - a Trial on the Effect of Morphine and Oxycodone in Patients Undergoing PCNL
|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 ]
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|