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Trial registered on ANZCTR


Registration number
ACTRN12611001018909
Ethics application status
Approved
Date submitted
21/09/2011
Date registered
22/09/2011
Date last updated
22/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tramadol administration in the critically ill
Scientific title
Pharmacokinetics of Subcutaneous Tramadol in Intensive Care Unit (ICU) step down patients
Secondary ID [1] 263086 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care Unit (ICU) Step Down patients who require patient controlled analgesia (PCA) Fentanyl as part of their management after trauma or surgery. 270838 0
Condition category
Condition code
Anaesthesiology 271017 271017 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tramadol Hydrochloride 50mg one injection only on study day. Administered over 1 minute subcutaneously
Intervention code [1] 269436 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279678 0
Rate of absorption of Tramadol administered subcutaneously as indicated by serum concentration of racemic tramadol and urine concentrations of tramadol and its M1 (o-demethyltramadol) and M2 (mono-N-demethyltramadol) metabolites
Timepoint [1] 279678 0
t=0(pre-dose), 2, 5, 10, 15, 30, 60, 90, 120, 180, 240, 300, 360, 480min and 24h after injection
Secondary outcome [1] 294172 0
Time to peak of Tramadol administered subcutaneously as indicated by serum concentration of racemic tramadol and urine concentrations of tramadol and its M1 (o-demethyltramadol) and M2 (mono-N-demethyltramadol) metabolites
Timepoint [1] 294172 0
t=0(pre-dose), 2, 5, 10, 15, 30, 60, 90, 120, 180, 240, 300, 360, 480min and 24h after injection

Eligibility
Key inclusion criteria
ICU Step down patients who require patient controlled analgesia(PCA) Fentanyl as part of their management after trauma or surgery
Adequate venous access to collect blood
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication and/or allergy to the use of Tramadol or Fentanyl
Significant hepatic impairment (3 times the limit of upper range Liver Function Test)
Chronic use of central nervous system depressants
Drugs that inhibit CYP2D6 activity
History of epilepsy
Renal dysfunction (creatinine clearance of less than or equal to 75ml/min)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Informed consent obtained
2. Administration of subcutaneous Tramadol in all subjects (15 subjects)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269905 0
University
Name [1] 269905 0
University of Adelaide
Address [1] 269905 0
Discipline of Acute Care Medicine
North Terrace
Adelaide
South Australia 5000
Country [1] 269905 0
Australia
Primary sponsor type
Individual
Name
Guy Ludbrook
Address
Discipline of Acute Care Medicine
University of Adelaide
North Terrace
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 268916 0
Individual
Name [1] 268916 0
Associate Professor Marianne Chapman
Address [1] 268916 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [1] 268916 0
Australia
Secondary sponsor category [2] 268917 0
Individual
Name [2] 268917 0
Associate Professor Pamela Macintyre
Address [2] 268917 0
Department of Anaesthesia
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [2] 268917 0
Australia
Secondary sponsor category [3] 268918 0
Individual
Name [3] 268918 0
Dr Krishnaswamy Sundararajan
Address [3] 268918 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [3] 268918 0
Australia
Secondary sponsor category [4] 268919 0
Individual
Name [4] 268919 0
Dr Jennifer Ong
Address [4] 268919 0
University of Adelaide
Discipline of Acute Care Medicine
North Terrace
Adelaide
South Australia 5000
Country [4] 268919 0
Australia
Secondary sponsor category [5] 268920 0
Individual
Name [5] 268920 0
Dr Richard Upton
Address [5] 268920 0
Department of Anaesthesia
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [5] 268920 0
Australia
Secondary sponsor category [6] 268921 0
Individual
Name [6] 268921 0
Stephanie O'Connor
Address [6] 268921 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [6] 268921 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271877 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 271877 0
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 271877 0
Australia
Date submitted for ethics approval [1] 271877 0
Approval date [1] 271877 0
10/08/2009
Ethics approval number [1] 271877 0
090719

Summary
Brief summary
The study enabled dosing intervals, peak plasma concentration and rate of absorption of subcutaneous tramadol to be determined in Intensive Care Step Down Unit patients. It also permitted pharmacokinetic comparison with other subcutaneous opioids and assist in clinical decision-making about optimal opioid dosing regimens for moderate to severe acute pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33189 0
Address 33189 0
Country 33189 0
Phone 33189 0
Fax 33189 0
Email 33189 0
Contact person for public queries
Name 16436 0
Dr Krishnaswamy Sundararajan
Address 16436 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 16436 0
Australia
Phone 16436 0
+61 8 8222 4624
Fax 16436 0
Email 16436 0
Krishnaswamy.Sundararajan@health.sa.gov.au
Contact person for scientific queries
Name 7364 0
Dr Jennifer Ong
Address 7364 0
Deiscipline of Acute Care Medicine
Univerisity of Adelaide
North Terrace
Adelaide
South Australia 5000
Country 7364 0
Australia
Phone 7364 0
+61 8 8303 5909
Fax 7364 0
Email 7364 0
jennifer.ong@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary