The optimal dose of subcutaneous naloxone for the treatment of intrathecal opioid- induced pruritus following elective caesarean section delivery - Optimal dose of naloxone for neuraxial opioid induced pruritus

• Conditions: Pruritus secondary to intrathecal opioids; MedDRA version: 9.1Level: LLTClassification code 10049981Term: Drug-induced pruritus

• Registration Number: EUCTR2007-007815-99-GB
• Lead Sponsor: eeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Females aged between 18 to 45 years of age who are booked for elective caesarean section delivery.
Written consent obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Concurrent opioid therapy – prescribed or illicit
•Patients in whom spinal anaesthesia is contra-indicated
•Allergy to naloxone
•Naloxone use within 1 week
•Patients that undergo general anaesthesia with no spinal opioid administered
•Patients with a past medical history of liver disease eg cholestasis in pregnancy
•Patients with a past medical history of kidney disease and a blood creatinine level of over 200 micromol/L.
•Patients with severe acute cardiac dysfunction eg unstable angina, MI within the last 3 months, arrythmias or decompensated cardiac failure from medical history
•Patients in whom non steroidal anti-inflammatory drugs are contra-indicated
•Poor comprehension of assessment tools at the preassessment clinic eg
visual analogue pruritus scale (VAPRS).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified