This is an investigator led, randomised, double blind, placebo controlled, double arm comparator study.
Delayed respiratory depression is a well-documented side effect associated with the use of intrathecal morphine. This respiratory depression has implications for patient safety and necessitates either the observation of the patient in a high dependency setting for at least 24 hours or the use of an alternative analgesic technique. Other associated side effects include pruritus, nausea and vomiting and sedation. Naloxone is the most effective treatment for these side effects. However, it is usually given as a reactive treatment when the side effect presents. The hypothesis is that patients who are commenced on a naloxone infusion at low dose early after injection of intrathecal morphine will have a clinically significant reduction in incidence of these side effects. The primary endpoint is a reduction in respiratory depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
96
Prof. Alistair Nichol
Dublin, Ireland
Respiratory depression
Time frame: within 16 - 24 hours of participation
Measure of occurrence of pain
Time frame: within 16 - 24 hours of participation
Requirement for rescue analgesia
Time frame: within 16 - 24 hours of participation
Nausea/Vomiting
Time frame: within 16 - 24 hours of participation
Pruritus
Time frame: within 16 - 24 hours of participation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.