Active surveillance of overdose with a prolonged-release formulation of tramadol/paracetamol. The PICS study.

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:
  Cohort

  Other
• Non-interventional study design, other:
  Intensive monitoring schemes

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (N02AJ13) tramadol and paracetamol

  tramadol and paracetamol
• Medical condition to be studied:
  Toxicity to various agents

  Overdose

Population studied

• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  30

Study design details

• Main study objective:
  The main objective is: • to evaluate the effectiveness of risk minimisation measures in reducing the risk of hepatotoxicity after the overdose with the product
• Outcomes:
  Primary outcomes include: • Total number of overdose cases with OMP treated in our study • The ratio of cases with serious sequelae related to paracetamol poisoning, with respect to total number of cases treated in our study, The secondary outcomes encompass 27 items related with: • Demography /Vital signs/Comorbidities • Concomitant therapy including those involved in the overdose • Exposure and clinical/laboratory characteristics • Therapy characteristics • Disease outcomes
• Data analysis plan:
  The study is primarily descriptive and non-comparative. Qualitative data (e.g. gender, concomitant diseases, etc.) will be summarized by frequency count and percentages. Percentages will be calculated using the number of patients in the relevant population as the denominator. Quantitative data (e.g. age, body weight, blood pressure, etc.) will be summarized by appropriate descriptive statistics. Where appropriate, 95% confidence intervals will be presented. An interim analysis is planned to be carried out in this study with the interim data capture point of August 1, 2023. Data from all patients participated in this study will be used in the analysis, due to expected small sample size, no center effect will be assessed.