Primary objective:Can a difference between the change in the perception of pain over time (0-60 minutes) between tramadol and butylscopolamine in renal colic be proven?Secundary objectives:- Can a difference in the decline in VAS-score over time (0-…
ID
Source
Brief title
Condition
- Urolithiases
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy of treatment is defined as a decline of 10 mm or more on the
horizontal Visual Analogue Scale. Differences between the tramadol and
butylscopolamine groups will be calculated with change in VAS-score between T0
and T3(60 min)
Secondary outcome
Secundary objectives:
- Can a difference in the decline in VAS-score over time (0-240 minutes)
between the tramadol group and the butylscopolamine group be proven?
The decline in VAS-score will be compared between the tramadol and
butylscopolamine group at the different time
intervals.
- Can the therapeutic efficacy of butylscopolamine compared to placebo over
time (0-240 minutes) be proven?
A significant difference between the butylscopolamine group and the placebo
group will be marked as prove.
- Can the therapeutic efficacy of tramadol compared to placebo over time (0-240
minutes) be proved?
A significant difference between the tramadol group and the placebo group will
be marked as prove.
- What are the side effects of continuous intravenous administered tramadol and
to what extend do they occur?
Side -effects are being scored as present or absent. The presence of
side-effects will be presented as a percentage of the total number of patients
treated with studymedication.
- Is a difference in the need for of rescue-medication seen between the
tramadol and the butylscopolamine group?
Background summary
Traditional treatment of renal colic is administration of an NSAID, combined
with intravenous administration of butylscopolamine. This treatment often needs
additional opioid analgesics to reach relief of pain. Opioids are administered
when pain does not sufficiently declines after treatment with NSAID's and
butylscopolamine. There for it takes longer to relief the renal colic pain.
This study investigates the efficacy of continuous intravenous administration
of tramadol in renal colic pain and aims to support the results of Mortelmans
et al (J Endourol 2006;20:1010-1015).
Study objective
Primary objective:
Can a difference between the change in the perception of pain over time (0-60
minutes) between tramadol and butylscopolamine in renal colic be proven?
Secundary objectives:
- Can a difference in the decline in VAS-score over time (0-240 minutes)
between the tramadol group and the butylscopolamine group be proven?
- Can the therapeutic efficacy of butylscopolamine compared to placebo over
time (0-240 minutes) be proved?
- Can the therapeutic efficacy of tramadol compared to placebo over time (0-240
minutes) be proved?
- What are the side effects of continuous intravenous administered tramadol and
to what extend do they occur?
- Is a difference in the need for of rescue-medication seen between the
tramadol and the butylscopolamine group?
Study design
There has been chosen for a prospective, randomized, double-blinded,
placebo-controlled, clinical trial. The study population consists of three
groups. The tramadol group, the butylscopolamine group and the placebogroup.
I refer for further information to the flowchart of this study.
Study burden and risks
The time and energy which has to be spent by the participants is negligible.
Vital parameters will be measured non-invasive by the nursing staff at the
different time intervals and the participants will have to score their pain on
the VAS-score. Treatment with tramadol intravenous seems safe and side-effects
are considered as minor. There for there will be no greater risk than in
traditional treatment for renal colic for the participants.
Groot Wezenland 20
8000 GM Zwolle
NL
Groot Wezenland 20
8000 GM Zwolle
NL
Listed location countries
Age
Inclusion criteria
Adults 18 years and older
Written and oral informed consent obtained
Mental capacity to make a will
Exclusion criteria
Pregnancy / lactation
Chronic tramadol use
Renal insufficiency, creatinine clearance < 10 ml/min
Hepatic insufficiency
Severe COPD / respiratory insufficiency
Intolerance to NSAID's and/or opioids
Monoamine oxidase inhibitors use, or within 2 weeks after withdrawal
Narrow-angle glaucoma
Intoxication with alcohol or other drugs
NSAID use < 8 hours before presentation
Hydronephrosis together with fever
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-006198-98-NL |
| CCMO | NL18975.075.09 |