Bolus versus Continuous Study

• Research type

  Research Study

• Full title

  Comparison of the Effects of Intermittent Boluses to Simple Continuous Infusion on Patient Global Perceived Effect in Intrathecal Therapy for Pain.

• IRAS ID

  48203

• Contact name

  Sam Eldabe

• Eudract number

  2010-020087-38

• ISRCTN Number

  CCT-NAPN-19993 Appn Ref

• Research summary

  The use of implanted devices for the intrathecal (spinal) administration of drugs to relieve pain that is difficult to treat has been practiced for nearly thirty years. The advantage of the intrathecal (spinal) route is that, compared to oral medication or other routes, an equivalent, or better analgesic effect can be obtained with lower doses and therefore less severe side effects. In addition, the direct access to the intrathecal space allows the use of drugs that cannot be administered by another route because, either the body breaks down the drug and renders it inactive or because of its inability to cross the blood brain barrier. In this study we propose to compare the efficacy of the same daily dose of drugs administered by intermittent boluses compared to simple continuous infusion on the Patients?? reported Global Impression of Change. We postulate that administration of the same drugs by intermittent boluses will result in wider drug spread in the spinaflud (CSF) and spinal cord itself resulting in better pain relief for the patients.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/54

• Date of REC Opinion

  3 Aug 2010

• REC opinion

  Further Information Favourable Opinion