Oxycodone Concentration in the Blood After Oral Premedication

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Completed
• CT.gov ID: NCT03386318
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 28
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Oxycodone Concentration in the Blood After Oral Premedication
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: May 10, 2020
• Actual Study Completion Date: May 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Oxycodone concentration in the blood after oral premedication [2 days]

   Concentration study

2. Oxycodone concentrations and pain after oral premedication [7 day]

   Visual analoge Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: Female

Inclusion Criteria:

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

Exclusion Criteria:

• In complying to inclusion criterias

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska UH	Mölndal	Västra Götaland	Sweden	43180

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bengt Nellgard, Associate professor, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT03386318
• Other Study ID Numbers: Oxycodone premedication
• First Posted: Dec 29, 2017
• Last Update Posted: May 10, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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, Associate professor, Sahlgrenska University Hospital, Sweden: concentration
• Additional relevant MeSH terms: Oxycodone

Study Results

No Results Posted as of May 10, 2022