What place is there for tramadol/dexketoprofen?

Background

A National Institute for Health and Care Excellence (NICE) Clinical Knowledge Summary review on the management of mild to moderate acute pain suggests using paracetamol (up to 1g four times a day) as a first-line treatment option for adults.^R5,R6 The second step is to switch to a NSAID (e.g. ibuprofen) or, if the person is unable to take an NSAID, a weak opioid (e.g. codeine).⁶ Subsequent steps include paracetamol plus NSAID, or paracetamol plus a weak opioid; and paracetamol at its maximum dose plus a weak opioid at its maximum dose. When the pain intensity is moderate to intense, a short-term NSAID or weak opioid is recommended.^R5,R6 When the pain is very intense, a weak or strong opioid is recommended, depending on how urgently relief is needed.⁵ Combination analgesic products should generally be avoided as first-line treatment as they do not allow independent titration of each drug.

Assessment of pain

The individual rating of pain intensity is highly subjective and has significant inter- and intra-individual variability.^R7 Studies of analgesics, therefore, use multiple efficacy assessments and outcomes (see Box 1).

The European Medicines Agency (EMA) has published guidance on clinical trials for medicines intended to treat pain.⁹ The EMA has advised that self-assessment scales provide the most valid measure of the patient’s experience and that no validated objective measures are available that would be feasible in clinical trials. Pain intensity (PI) is the key measure of efficacy of an analgesic drug and among the pain rating scales, the visual analogue scale (VAS), numeric rating scale (NRS) and verbal rating scale (VRS) have been extensively used and validated.

Tramadol/dexketoprofen

The summary of product characteristics (SPC) states that the product is indicated for “symptomatic short-term treatment of moderate to severe acute pain in adult patients whose pain is considered to require a combination of tramadol and dexketoprofen”,³ although how patients would be classified as requiring these drugs is not stated. The dose is one tablet (75mg tramadol hydrochloride and 25mg dexketoprofen) with additional doses taken as needed at least 8 hours apart. The total daily dose should not exceed three tablets per day and treatment should not exceed 5 days. Administration with food delays absorption, so a faster effect...