NCT03386318

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 29, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.4 years

First QC Date

December 21, 2017

Last Update Submit

May 9, 2022

Conditions

Oxycontin

Keywords

concentration

Outcome Measures

Primary Outcomes (2)

  • Oxycodone concentration in the blood after oral premedication

    Concentration study

    2 days

  • Oxycodone concentrations and pain after oral premedication

    Visual analoge Scale

    7 day

Study Arms (1)

day surgery patients

20 patients female 30-60 years of age

Drug: Oxycodone

Interventions

OxycodoneDRUG

Serum concentration per hour from 1 to 5 h

day surgery patients

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska UH

Mölndal, Västra Götaland County, 43180, Sweden

Location

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 21, 2017

First Posted

December 29, 2017

Study Start

January 1, 2019

Primary Completion

May 10, 2020

Study Completion

May 1, 2021

Last Updated

May 10, 2022

Record last verified: 2022-05

Locations

SE(1)