Optimal dose of naloxone for neuraxial opioid induced pruritus

• Research type

  Research Study

• Full title

  The optimal dose of subcutaneous naloxone for the treatment of opioid induced pruritus following elective caesarean section

• IRAS ID

  1721

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Eudract number

  2007-007815-99

• ISRCTN Number

  n/a

• Research summary

  Itch, or pruritus, following spinal anaesthesia for caesarean section surgery affects up to 80% of women. One quarter of these women will request treatment for this side effect and the only available treatment is a drug called naloxone. Too small a dose will be ineffective but too big a dose risks increasing wound pain after surgery. The aim of this study is to find the best dose of naloxone that treats pruritus but avoids reversing the pain relief offered by spinal anaesthesia. Potential benefits include a reduction in side effects following surgery, namely pruritus and nausea or vomiting. This is a randomised, controlled double-blind study which is funded by the Obstetric Anaesthetists' Association. It is a single centred study which will take place at St James Hospital, Leeds. After surgery, patients who request treatment for pruritus will fall into one of three groups and receive either 0.1mg, 0.25mg or 0.4mg of naloxone. Patients will be followed up over eight hours post spinal anaesthesia and their subjective experience of itch, pain and nausea or vomiting will be measured using visual analogue scales. During this follow up period, patients will have the opportunity to request extra treatment for itch, pain or nausea. Any further doses of naloxone will not be blinded and will be the standard departmental dose of 0.1mg. All this will be recorded for final data analysis. Patients who experience itch as a side effect but do not wish treatment will also be followed up in a similar manner, and will act as a comparator group. We hope to improve patient care by identifying the best dose to treat this side effect, so women are not exposed to repeated injections of naloxone while remaining comfortable following surgery.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  08/H0605/162

• Date of REC Opinion

  12 Jan 2009

• REC opinion

  Further Information Favourable Opinion