EUCTR2006-002370-21-GBActive, not recruitingPhase 1
Comparison of oral and intravenous paracetamol plasma levels when given as premedication for perioperative analgesia - Paracetamol Study
orth Bristol NHS Trust0 sites104 target enrollmentStarted: July 23, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 104
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1) ASA I and II (Patients who are fit medically or only have mild systemic disease, for example treated high bloodpressure -
- •disease that does not limit daily activities)
- •2) Age group 16 – 75 years (to exclude children who can not give consent)
- •3) Specific operative list: Mr. P Robinson Ear, Nose & Throat surgery
- •This patient group will benefit from the type of pain relief effect that paracetamol has.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1) Patients refusing to participate in study.
- •2) Patient unable to take an oral preparation.
- •3) Cases shorter than one hour.(Less than that to short to complete bloodtest and all paperwork for anaesthetic)
- •4) Patients already taking a paracetamol containing drug combination, or have taken in the last 12 hrs.(Bloodlevels will be
- •5) Patients with a history of paracetamol allergy, hypersensitivity or previous reaction / serious adverse reaction.
- •6) Children under the age of 16 (Can not give consent)
- •7) Patients unable to understand or give consent to participation in the study; incapable adults, psychiatric / medical disorder
- •able to modify patient compliance.
- •8) Pregnant or breastfeeding
- •9) History of complete non-responsiveness to acetaminophen (Paracetamol)
- •10) Pancreatic disease in the previous 12 months (Influences the metabolism of paracetamol)
- •11) Impaired liver/ kidney function
- •12) (Patients that might pose an infection risk to staff – blood products)
- •A24. Will the participants be from any of the following groups?(Tick as appropriate)
Investigators
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