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Sickle Cell Analgesia Protocol Evaluation (SCAPE)

  • Research type

    Research Study

  • Full title

    Phase II evaluation of sub lingual fentanyl combined with oral oxycodone for acute pain management in adolescents and adults with acute painful crisis of sickle cell disease

  • IRAS ID

    124241

  • Contact name

    Paul Telfer

  • Contact email

    paul.telfer@bartshealth.nhs.uk

  • Sponsor organisation

    Barts Health NHS Trust

  • Eudract number

    2013-004161-14

  • Research summary

    Sickle Cell Disease (SCD) is a common inherited blood condition in African and Caribbean ethnic minority populations. The commonest complication of SCD is the acute painful crisis(APC), which may require pain management in hospital with opoiod (morphine-like) drugs. Children are usually treated with morphine given orally, whilst adults are usually presecibed morphine injections. These are uncomfortable, do not provide smooth pain control, and cause unpleaseant side effects. The more potent chemically modified opoiods such as fentanyl and oxycodone may act more quickly, more reliably and with fewer adverse effects.
    We plan to develop an oral-based pain managment protocol for adolescents and adults using sub lingual fentanyl (dissolved under the tongue and directly absorbed into the blood stream) for immediate analgesia and oral oxycodone for continued, sustained analgesia. The protocol will include clear directions about monitoring for side effects and complications of APC.
    The first objective is to establish the safe dose (maximum tolerated dose)for sub lingual fentanyl (Abstral®) when given with Oxynorm®, a short acting oral formulation of oxycodone. The second objective is to obtain initial data on the effectiveness, safety and acceptability of the protocol, and to determine the feasibility of conducting a larger, multi-centre romparative trial in APC in which this protocol, the SCAPE protocol, will be compared with standard care (probably injected morphine).

  • REC name

    London - City & East Research Ethics Committee

  • REC reference

    14/LO/0165

  • Date of REC Opinion

    17 Jun 2014

  • REC opinion

    Further Information Favourable Opinion