Survey of Postoperative Pain and Pain Management in Norwe... | NCT01413724

Studies
Survey of Postoperative Pain and Pain Management in Norwegian Hospitals

NCT01413724

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Aug 3, 2016Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Pain, Postoperative

Interventions

Not provided

Countries

Not provided

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

Aug 2016

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

Jun 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jul 22, 2010

First Submission Date that Met QC Criteria

Aug 9, 2011

First Posted Date

Aug 10, 2011Estimated

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

Aug 2, 2016

Last Update Posted Date

Aug 3, 2016Estimated

Name	Class
Norwegian Pain Association	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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 study is a national survey of pain and pain management to surgical patients in Norwegian Hospitals. Data on pain management are gathered from patient records and data on pain and patient satisfaction are gathered as patients' self report.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical patients		PAtients who had surgery the previous day and are still hospitalized

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	Proportion of patients who report average pain intensity >3 on 11 point pain Numerical Rating scale for the first 24 hours after surgery	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgery previous day

Exclusion Criteria:

Declined participation
Unable to communicate (delirious, sedated, intubated)
Does not read and speak Norwegian
Patient not available (for instance having physiotherapy og examinations during data collection)

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

All patients who had surgery the previous day and still are hospitalized. Patients must give informed consent to participate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olav M Fredheim, MD, PhD, MBA	Norwegian University of Science and Technology	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21946593	Result	Fredheim OM, Kvarstein G, Undall E, Stubhaug A, Rustoen T, Borchgrevink PC. [Postoperative pain in patients admitted to Norwegian hospitals]. Tidsskr Nor Laegeforen. 2011 Sep 20;131(18):1763-7. doi: 10.4045/tidsskr.10.1129. Norwegian.
21946595	Result	Fredheim OM, Borchgrevink PC, Kvarstein G. [Post-operative pain management in hospitals]. Tidsskr Nor Laegeforen. 2011 Sep 20;131(18):1772-6. doi: 10.4045/tidsskr.10.1184. Norwegian.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain