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Clinical Trials/EUCTR2006-002370-21-GB
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

Sponsor
orth Bristol NHS Trust

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