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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03386318
Other study ID # Oxycodone premedication
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date May 1, 2021

Study information

Verified date May 2022
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 1, 2021
Est. primary completion date May 10, 2020
Accepts healthy volunteers
Gender Female
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - Females <100kg, non-opioid tolerant, day surgery and informed consent Exclusion Criteria: - In complying to inclusion criterias

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Oxycodone
Serum concentration per hour from 1 to 5 h

Locations

Country Name City State
Sweden Sahlgrenska UH Mölndal Västra Götaland

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxycodone concentration in the blood after oral premedication Concentration study 2 days
Primary Oxycodone concentrations and pain after oral premedication Visual analoge Scale 7 day