Visceral Pain From the Upper Urinary Tract - a Trial on t... | NCT00784472

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

NCT00784472

Sponsor

Katja venborg Pedersen

Status

Completed

Last Update Posted

Jul 9, 2012Estimated

Enrollment

55Actual

Phase

Phase 3

Conditions

Kidney Stones

Interventions

oxycodone
morphine

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Oct 27, 2008

First Submission Date that Met QC Criteria

Nov 3, 2008

First Posted Date

Nov 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2012

Last Update Posted Date

Jul 9, 2012Estimated

Name	Class
Aalborg University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oxycodone	Active Comparator		Drug: oxycodone
morphine	Active Comparator		Drug: morphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxycodone	Drug	intravenous according to patients weight, pn.	oxycodone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of analgetics used		four hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Side effects		four hours postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Little Belt, Fredericia		Fredericia		7000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D059265	Visceral Pain

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010098	Oxycodone
D009020	Morphine

Ancestor Terms

ID	Term
D003061	Codeine
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided