Pruritus secondary to intrathecal opioids MedDRA version: 9.1 Level: LLT Classification code 10049981 Term: Drug-induced pruritus
Conditions
Interventions
Product Name: Naloxone
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NALOXONE
CAS Number: 465656
Current Sponsor code: AN07/8429
Other descriptive name:
Sponsors
Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find the best dose of naloxone that efectively treats drug-induced pruritus, in terms of reduction in pruritus scores and duration of action.;Secondary Objective: To assess side effect profile of each dose of naloxone by assessing the effect on duration of analgesia and need for rescue analgesia. Assess effect on nausea and vomiting. Assess pruritus scores between patients who request and those that do not request treatment for pruritus. ;Primary end point(s): Visual analogue scores for pruritus at 2hr, 3hr, 4hr, 5hr, 6hr, 7hr, 8hr and 24 hours post spinal anaesthesia Need for rescue anti-pruritic therapy (in the form of unblinded doses of naloxone) | — |
Countries
United Kingdom
Outcome results
None listed