Acute Pain and Inflammation After Surgery | NCT00774540

Studies
Acute Pain and Inflammation After Surgery

NCT00774540

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Apr 23, 2015Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Knee Injuries

Interventions

1 Ketorolac intraarticular
Placebo

Countries

Norway

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
S-04342

Status Module

Record Verification Date

Apr 2015

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

Aug 2008

Primary Completion Date

Sep 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 16, 2008

First Submission Date that Met QC Criteria

Oct 16, 2008

First Posted Date

Oct 17, 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

Apr 22, 2015

Last Update Posted Date

Apr 23, 2015Estimated

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 observe acute pain after surgery and measure the natural course of inflammatory mediators
study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac

Detailed Description

Randomizized controlled trial

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Ketorolac	Drug: 1 Ketorolac intraarticular
2	Placebo Comparator	saline	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
1 Ketorolac intraarticular	Drug	Ketorolac intraarticular 5 mg	1	Ketorolac

Measure	Description	Time Frame
Pain relief local anti-flammatory effects		2 h

Measure	Description	Time Frame
Rescue analgesic consumption		2 h

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Day case surgical patients above 18 years old
Non pregnant

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leiv Arne Rosseland	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital, Division of Emergencies and Critical Care		Oslo		0242	Norway

Type	Date	Date Unknown
Release	Nov 28, 2023
Reset	May 3, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 28, 2023			May 3, 2024

Condition Browse Module

MeSH Terms

ID	Term
D007718	Knee Injuries
D059787	Acute Pain

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries
D010146	Pain
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020910	Ketorolac
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided