Tramadol administration in the critically ill

Pharmacokinetics of Subcutaneous Tramadol in Intensive Care Unit (ICU) step down patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001018909

Enrollment

Registered

2011-09-22

Start date

2010-04-24

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Tramadol Hydrochloride 50mg one injection only on study day. Administered over 1 minute subcutaneously

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

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)

Outcome results