OxycontinNCT03386318
Oxycodone Concentration in the Blood After Oral Premedication
An observational study of Oxycontin, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Oxycontin
- What is being tested?
- Oxycodone
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2019to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- Adult
Study population: Female between 30-60 years under 100 kg non-opiod tolerant
Who may be able to join
- Females <100kg, non-opioid tolerant, day surgery and informed consent
Who cannot join
- In complying to inclusion criterias
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Serum concentration per hour from 1 to 5 h
| Study group | Role | What they receive |
|---|---|---|
| day surgery patients | 20 patients female 30-60 years of age Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxycodone concentration in the blood after oral premedication
Concentration study
Measured: 2 days
Oxycodone concentrations and pain after oral premedication
Visual analoge Scale
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start1 Jan 2019
- Primary completion10 May 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OxycontinStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengt Nellgard, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386318
- Sponsor's protocol ID
- Oxycodone premedication
- Status last verified
- May 2022
- First submitted
- 21 Dec 2017
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Concentrations found of investigated drug
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxycodone Concentration in the Blood After Oral Premedication
- ClinicalTrials.gov ID
- NCT03386318
- Acronym / sponsor ID
- Oxycodone premedication
- Conditions
- Oxycontin
- Keywords
- concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| day surgery patients | – | Drug: Oxycodone20 patients female 30-60 years of age |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Female between 30-60 years under 100 kg non-opiod tolerant
Key inclusion criteria (1 listed)
- Females <100kg, non-opioid tolerant, day surgery and informed consent
Key exclusion criteria (1 listed)
- In complying to inclusion criterias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxycodoneSerum concentration per hour from 1 to 5 h | Drug | day surgery patients |
Primary outcome
Oxycodone concentration in the blood after oral premedication
Time frame: 2 days
Concentration study
Oxycodone concentrations and pain after oral premedication
Time frame: 7 day
Visual analoge Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: Undecided. Concentrations found of investigated drug
Related trials for Oxycontin
Not yet recruitingPhase 4
Examining Analgesic Synergy and Efficacy in Trauma Care
Opioid Use Disorder
RecruitingPhase 4
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
Healthy
Not yet recruitingObservational study
Real-world Study of the Effectiveness and Tolerability of Outpatient Titration of OxyContin for the Moderate and Severe Pain in Cancer Patients
Cancer Pain
Enrolling by invitationPhase 4
Reducing Opioid Use After Upper Extremity Surgery: Testing Lower Prescriptions and Pill Quantity
Opioid Abuse (Disorder), Opioid Analgesia
Not yet recruitingPhase 4
Post-op Analgesia of Nail Unit Procedures
Nail Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxycontin, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxycodone concentration in the blood after oral premedication (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.