Tramadol administration in the critically ill
Phase 4
Completed
- Conditions
- Intensive Care Unit (ICU) Step Down patients who require patient controlled analgesia (PCA) Fentanyl as part of their management after trauma or surgery.Anaesthesiology - Pain management
- Registration Number
- ACTRN12611001018909
- Lead Sponsor
- Guy Ludbrook
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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[t=0(pre-dose), 2, 5, 10, 15, 30, 60, 90, 120, 180, 240, 300, 360, 480min and 24h after injection]
- Secondary Outcome Measures
Name Time Method 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[t=0(pre-dose), 2, 5, 10, 15, 30, 60, 90, 120, 180, 240, 300, 360, 480min and 24h after injection]