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Oxycodone Concentration in the Blood After Oral Premedication

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ClinicalTrials.gov Identifier: NCT03386318
Recruitment Status : Not yet recruiting
First Posted : December 29, 2017
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Bengt Nellgard, Sahlgrenska University Hospital, Sweden

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

Condition or disease Intervention/treatment
Oxycontin 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
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oxycodone Concentration in the Blood After Oral Premedication
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Oxycodone concentration in the blood after oral premedication [ Time Frame: 2 days ]
    Concentration study

  2. Oxycodone concentrations and pain after oral premedication [ Time Frame: 7 day ]
    Visual analoge Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female between 30-60 years under 100 kg non-opiod tolerant
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • In complying to inclusion criterias

Responsible Party: Bengt Nellgard, Associate professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03386318     History of Changes
Other Study ID Numbers: Oxycodone premedication
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Concentrations found of investigated drug

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

Keywords provided by Bengt Nellgard, Sahlgrenska University Hospital, Sweden:
concentration

Additional relevant MeSH terms:
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents