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

Sponsor:	Fredericia Hosptial
Collaborator:	Aalborg Hospital
Information provided by:	Fredericia Hosptial
ClinicalTrials.gov Identifier:	NCT00784472

Purpose

The purpose of this study is to investigate the effect of oxynorm versus morphine after operation for kidney stone (PCNL). In addition the relationship between pain symptoms and referred sensory and trophic changes will be examined in the patients before and after the operation.Finally a blood sample is analysed to investigate pharmaca-genetics.

Condition	Intervention	Phase
Kidney Stones	Drug: oxycodone Drug: morphine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Kidney Stones

Drug Information available for: Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

Further study details as provided by Fredericia Hosptial:

Primary Outcome Measures:

Amount of analgetics used [ Time Frame: four hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side effects [ Time Frame: four hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: oxycodone	Drug: oxycodone intravenous according to patients weight, pn. Other Name: oxynorm N02A A05
Active Comparator: morphine	Drug: morphine intravenous administration according to patients weight, pn. Other Name: morphine SAD N02 AA 01

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18
Indication for PCNL

Exclusion Criteria:

Malignant disease in the upper urinary tract
Allergy to morphine or oxycodone
Use of opioids the last 48 hours before PCNL
Pregnancy
Nursing mothers
Present JJ-stent in the ureter
Previous urinary stone disease on the opposite site

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784472

Contacts

Contact: Katja venborg pedersen, MD

0045 76237339

katja.venborg@slb.regionsyddanmark.dk

Locations

Denmark
Hospital Little Belt, Fredericia	Recruiting
Fredericia, Denmark, 7000
Contact: katja venborg Pedersen, MD 0045 76237339 katja.venborg@slb.regionsyddanmark.dk
Contact katjavenborg@yahoo.dk
Principal Investigator: Katja venborg Pedersen, MD

Sponsors and Collaborators

Fredericia Hosptial

Aalborg Hospital

Investigators

Study Chair:	Palle Osther, Professor	Hospital Little Belt, Fredericia
Principal Investigator:	katja Venborg Pedersen, MD	Hospital Little Belt, Fredericia

More Information

No publications provided

Responsible Party:	Professor Palle Osther, Hospital Little Belt, Fredericia
ClinicalTrials.gov Identifier:	NCT00784472 History of Changes
Other Study ID Numbers:	VEN 1
Study First Received:	October 27, 2008
Last Updated:	June 22, 2011
Health Authority:	Denmark: National Board of Health

Keywords provided by Fredericia Hosptial:

PCNL
oxycodone
morphine
visceral pain

Additional relevant MeSH terms:

Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Morphine
Oxycodone

Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on February 09, 2012