Comparison of oral and intravenous paracetamol plasma levels when given as premedication for perioperative analgesia - Paracetamol Study

Phase 1

• Conditions: Peri-operative analgesia

• Registration Number: EUCTR2006-002370-21-GB
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-23
• Study Completion: 2009-12-04
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 104

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
affected)
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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Does paracetamol given into a vein give better pain relief during surgery than oral tablets when given to patients just before<br> surgery?<br> ;<br> Secondary Objective: Does paracetamol taken as a tablet reach adequate levels when absorbed into the blood to provide good pain relief when<br> given just 1 or 2 hours before surgery?<br> ;Primary end point(s): Paracetamol plasma levels