NCT02197741

The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Swiss Paraplegic Research, Nottwil · Network
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Pain Syndrome

Interventions

Type	Name	Description
DRUG	opiate with bolus

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-12-01
• Completion: 2014-07-01
• First posted: 2014-07-23
• Last updated: 2016-11-22