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

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Chronic Pain Syndrome

Treatments: Drug: opiate with bolus

Study type: Observational

Funder types: NETWORK

Identifiers

NCT02197741

2014-15

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic pain syndrome
• intrathecal opiate pump
• signed informed consent

Exclusion criteria

• younger than 18 years
• other (than opiate) intrathecal drug administration
• discontent with intrathecal opiate therapy

Trial design

10 participants in 2 patient groups

opiate without bolus

Description:

continuous opiate administration without bolus application

Treatment:

Drug: opiate with bolus

opiate with bolus

Description:

continuous opiate administration with additional bolus application

Treatment:

Drug: opiate with bolus