The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study
CompletedNCT02197741
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- The Effect of an Additional Bolus Application in Patients With Intrathecal Opiate Administration - a Pilot Study
- Conditions
- Interventions
- Drug: opiate with bolus
- Sponsor
- Swiss Paraplegic Research, Nottwil
- Start date
- 2012-02
- Primary completion
- 2012-12
- Sex
- All
- Age range
- from 18 Years to 99 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02197741