A comparison of the analgesic efficacy of oral and intravenous paracetamol (perfalgan) in a day case setting

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Auteurs
Catégorie Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Trade Name: Perfalgan Product Name: Intravenous (IV) paracetamol Pharmaceutical Form: Solution for infusion INN or Proposed INN: PARACETAMOL CAS Number: 103902 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: Paracetamol Product Name: oral paracetamol Pharmaceutical Form: Tablet INN or Proposed INN: PARACETAMOL CAS Number: 103902 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: We will perform a double blind randomised comparison of oral paracetamol versus intravenous paracetamol (Perfalgan) in patients undergoing knee arthroscopy in a day surgery setting. PRIMARY OUTCOME: Main Objective: We will perform a double blind randomised comparison of oral paracetamol versus intravenous paracetamol (Perfalgan) in patients undergoing knee arthroscopy in a day surgery setting.; ; The main purpose of the trial will be to compare the analgesic effects of oral and intravenous paracetamol. Primary end point(s): Postoperative pain assessed by Visual Analogue Scale (VAS) scores and Verbal Rated Scale (VRS) scores during rest and during movement. Rescue analgesia required. Secondary Objective: To note any side effects of using Perfalgan INCLUSION CRITERIA: All patients on the list for day case knee arthroscopy aged between 18 to 60 years and weighing between 50 to 90 kg will be eligible for the study. 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) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 26e3bf392e170d03bf63e11c9ab789253daebf70
First added on: Aug 21, 2024