Oxycodone Concentration in the Blood After Oral Premedica... | NCT03386318

Studies
Oxycodone Concentration in the Blood After Oral Premedication

NCT03386318

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

May 10, 2022Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Oxycontin

Interventions

Oxycodone

Countries

Sweden

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

May 2022

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

Jan 1, 2019Actual

Primary Completion Date

May 10, 2020Actual

Completion Date

May 1, 2021Actual

First Submitted Date

Dec 21, 2017

First Submission Date that Met QC Criteria

Dec 28, 2017

First Posted Date

Dec 29, 2017Actual

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

May 9, 2022

Last Update Posted Date

May 10, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bengt Nellgard, Associate professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Oxycodone is an opioid frequently given orally as a premedication prior to any kind of surgery. The initial studies are performed on healthy testpersons and is not given in surgery. The investigators want to explore serum concentration over time (5h) and relate this to Visual Analoge Scale (VAS) postoperatively but also to given mg/kg

Detailed Description

Oxycodone is an opioid frequently given orally as a premedication prior to any kind of surgery. The initial studies are performed on healthy test-persons and is not given in surgery. The investigators want to explore serum concentration over time (5h) and relate this to Visual Analoge Scale (VAS) postoperatively but also to given mg/kg 20 female patients between 30 and 60 years will be included after informed consent. They will have day-surgery. The patients will receive 5 mg oxycodone if weighing less than 60 kg and 10 mg if weighing over 60 kg. Serum samples will be taken 1, 2,3,4, and 5 hours after medication intake and serum concentrations will be analyzed

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
day surgery patients		20 patients female 30-60 years of age	Drug: Oxycodone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone	Drug	Serum concentration per hour from 1 to 5 h	day surgery patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxycodone concentration in the blood after oral premedication	Concentration study	2 days
Oxycodone concentrations and pain after oral premedication	Visual analoge Scale	7 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Females <100kg, non-opioid tolerant, day surgery and informed consent

Exclusion Criteria:

In complying to inclusion criterias

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Female between 30-60 years under 100 kg non-opiod tolerant

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska UH		Mölndal	Västra Götaland County	43180	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Concentrations found of investigated drug

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

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