The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
An additional, intermittent bolus application in patients with intrathecal opiate
administration for chronic pain syndrome may have a positive effect on the effectiveness of
the treatment. Thus, the effect of an additional, intermittent bolus application in patients
with intrathecal opiate administration was therefore investigated.
Patients already equipped with an intrathecal opiate pump were enrolled into the study. Each
patient was submitted to two treatment periods in randomly chosen order (cross-over design):
1. standard treatment (continuous opiate administration) and 2. continuous opiate
administration with intermittent opiate bolus application. Both treatment periods lasted 14
days. Patients were asked to record pain intensity, side effects and satisfaction with the
treatment.
The following hypotheses were tested:
- The application of additional opiate boli results in significantly lower pain intensity.
- The application of additional opiate boli does not result in a higher rate of adverse
Events.