Post Authorisation Safety Study (PASS) to Evaluate the Risks of Hepatotoxicity and Nephrotoxicity from Administration of Methoxyflurane (Penthrox®) for Pain Relief in Hospital Accident & Emergency Departments in the United Kingdom (Penthrox-PASS)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine, other:
  Penthox
• Study drug International non-proprietary name (INN) or common name:
  METHOXYFLURANE
• Medical condition to be studied:
  Pain management

Population studied

• Short description of the study population:
  250 patients for the patient survey and 250 HCPs for the HCP survey
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  250

Study design details

• Main study objective:
  The main objective is to measure awareness, usage, readability, knowledge and understanding of the messages, and impact on behavioural implementation of key safety information contained in the HCP administration guide and checklist, and in the patient alert card among HCPs and patients.
• Outcomes:
  To measure awareness, usage, readability, knowledge and understanding of the messages, and impact on behavioural implementation of key safety information contained in the HCP administration guide and checklist, and in the patient alert card among HCPs and patients. - Major determinants of HCP and patient understanding and implementation regarding key messages. - Measures of awareness, usage, readability, knowledge, understanding and behaviour reported by HCPs and patients in the survey will be correlated with clinical data collected in the context of the twin PASS.
• Data analysis plan:
  Analyses will be mainly descriptive in nature. Categorical data will be summarized by counts and percentages. Continuous data will be summarized using number, mean, standard deviation (SD), median, quartiles, minimum and maximum and in the case of non-normally distributed data, median, range and interquartile range. All statistical tests will be 2-sided and conducted at the 0.05 alpha level. P-values will be presented to three decimal places. A detailed statistical analysis plan (SAP) will be developed and approved before final database lock and will include methods of analysis and presentation and table shells.