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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02197741
Other study ID # 2014-15
Secondary ID
Status Completed
Phase N/A
First received July 4, 2014
Last updated November 21, 2016
Start date February 2012
Est. completion date July 2014

Study information

Verified date November 2016
Source Swiss Paraplegic Centre Nottwil
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 2014
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
opiate with bolus


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Swiss Paraplegic Centre Nottwil

Outcome

Type Measure Description Time frame Safety issue
Primary change in pain intensity numeric rating scale from 0 to10 day 0. day 14, day 28 No
Secondary change in satisfaction with treatment outcome numeric rating scale from 0 to 10 day 0, day 14, day 28 No
Secondary side effects occurrence rate of side effects from day 0 to day 28 No
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