Dose-response of Ketamine in Patient Controlled Analgesia... | NCT02994173

Studies
Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients

NCT02994173

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

Dec 11, 2019Actual

Enrollment

100Actual

Phase

Phase 4

Conditions

Pain, Postoperative

Interventions

Oxycodone
S-Ketamine 0.25
S-Ketamine 0.5
S-Ketamine 0.75

Countries

Finland

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

Dec 2019

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

Feb 1, 2017Actual

Primary Completion Date

Nov 3, 2019Actual

Completion Date

Dec 5, 2019Actual

First Submitted Date

Nov 3, 2016

First Submission Date that Met QC Criteria

Dec 13, 2016

First Posted Date

Dec 15, 2016Estimated

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

Dec 10, 2019

Last Update Posted Date

Dec 11, 2019Actual

Name	Class
University of Turku	OTHER
University of Helsinki	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation

Detailed Description

Not provided

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Active Comparator	Oxycodone 1 mg / ml alone	Drug: Oxycodone
Ketamine 0.25	Active Comparator	Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)	Drug: S-Ketamine 0.25
Ketamine 0.5	Active Comparator	Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)	Drug: S-Ketamine 0.5
Ketamine 0.75	Active Comparator	Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)	Drug: S-Ketamine 0.75

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone	Drug	Current clinical practice, used as a control in this study	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in opioid consumption (mg) postoperatively	Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours	24 and 72 hours

Secondary Outcomes

Measure	Description	Time Frame
Change in numerical rating scale (NRS 0-10)	Change from baseline NRS value postoperatively at 24 and 72 hours	24 and 72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20 - 75 years of age
Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
Written informed consent from the participating patient

Exclusion Criteria:

A previous history of intolerance to the study drug or related compounds and additives
Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.
Patients younger than 20 years and older than 75 years.
BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
Existing significant liver or kidney disease
History of ischemic heart disease or conduction disturbance
History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
Donation of blood for 4 weeks prior and during the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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
Marko Peltoniemi, MD, PhD	Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital		Turku		20521	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010098	Oxycodone

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided