[Consensus statement on the use of acetaminophen/tramadol in patients with moderate-severe pain]

To present recommendations on the use of the paracetamol/tramadol (P/T) combination in patients with moderate-intense pain based on best evidence and experience.

The method of nominal groups and Delphi was followed, and supported by a systematic literature review (SLR). A multidisciplinary panel of 12 experts in pain management was selected. In the first nominal group meeting, the aim, scope, users, and sections of the consensus document, were defined, along with the preliminary general recommendations. For the SLR, the inclusion and exclusion criteria, as well as the search strategies, were defined. Two reviewers selected and analysed the articles. This evidence was discussed in a second nominal group meeting, and definitive recommendations were developed. For each recommendation, the evidence levels and grade of recommendation grades were classified according to the Oxford model, and the grade according to the Delphi technique. It was defined as an agreement if at least 70% of the participants scored ≥7 for each recommendation (1=total disagreement to 10=total agreement).

A total of 20 recommendations were produced, which covered general aspects, such as the assessment of pain, and those specific to P/T management. These latter included the indications of the P/T combination (patient profile, dosing, prescription, formulations), risk management (contraindications, precautions, interactions, concomitant use with other medications, follow-up, special situations), and patient education.

These recommendations attempt to resolve any of the routine clinical questions, and help in the making of decisions on the use of the P/T combination in patients with moderate-intense pain.