MedTrace Logo

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

NCT02197741 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2016-11-22

No results posted yet for this study

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

DRUG

opiate with bolus

Sponsors & Collaborators

  • Swiss Paraplegic Research, Nottwil

    lead NETWORK

Principal Investigators

  • Tim Reck, MD · Center for Pain Medicine

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-12-31
Completion
2014-07-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02197741 on ClinicalTrials.gov