Oxycodone Concentration in the Blood After Oral Premedication

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

Study Overview

• Status: Completed
• Conditions: Oxycontin
• Intervention / Treatment: Drug: Oxycodone

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Sweden
  • Västra Götaland
    • Mölndal, Västra Götaland, Sweden, 43180
      • Sahlgrenska UH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• In complying to inclusion criterias

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
day surgery patients; 20 patients female 30-60 years of age	Drug: Oxycodone; Serum concentration per hour from 1 to 5 h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): May 10, 2020
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): December 29, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: concentration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: Oxycodone premedication

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Concentrations found of investigated drug

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No