Respiratory Depression Clinical Trial
Official title:
The NAPRESSIM Trial. The Use of Low Dose Prophylactic Naloxone Infusion to Prevent Respiratory Depression With Intrathecal Morphine.
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.
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