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OpenTrials
Completed

NCT Number: NCT02197741

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

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.

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Key information

Conditions

Chronic Pain Syndrome

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opiate with bolus

Drug

Primary outcomes

  1. change in pain intensity

    Time frame: day 0. day 14, day 28

    numeric rating scale from 0 to10

Secondary outcomes

  1. change in satisfaction with treatment outcome

    Time frame: day 0, day 14, day 28

    numeric rating scale from 0 to 10

  2. side effects

    Time frame: from day 0 to day 28

    occurrence rate of side effects

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Jul 23, 2014
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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