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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| opiate without bolus | continuous opiate administration without bolus application |
| |
| opiate with bolus | continuous opiate administration with additional bolus application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| opiate with bolus | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in pain intensity | numeric rating scale from 0 to10 | day 0. day 14, day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| change in satisfaction with treatment outcome | numeric rating scale from 0 to 10 | day 0, day 14, day 28 |
| side effects | occurrence rate of side effects |
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Inclusion Criteria:
Exclusion Criteria:
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individuals with chronic pain syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Tim Reck, MD | Center for Pain Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D053610 | Opiate Alkaloids |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| from day 0 to day 28 |